| Beta-CrossLaps CalCheck 5 (K170678) | Roche Diagnostics | 2017-04-04 |
| Elecsys CYFRA 21-1 CalCheck 5 (K162173) | Roche Diagnostics | 2017-01-12 |
| Multichem A1c (K162514) | Technopath Manufacturing | 2016-10-26 |
| Audit MicroControls Linearity DROP LQ Blood Glucose (K161874) | Aalto Scientific, Ltd. | 2016-08-10 |
| LIAISON EBV IgM Serum Control Set (K161522) | DiaSorin, Inc. | 2016-06-30 |
| LIAISON CMV IgM Serum Control Set (K161526) | DiaSorin, Inc. | 2016-06-30 |
| IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration Verifiers (K161082) | Immunodiagnostic Systems , Ltd. | 2016-05-17 |
| Dropper hsCRP High Sensitivity CRP Control (K152117) | Quantimetrix Corporation | 2016-04-21 |
| Contour Next Control Solution (K151742) | Bayer Healthcare | 2015-09-23 |
| ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material (K143687) | Siemens Healthcare Diagnostics, Inc. | 2015-07-17 |
| Elecsys Progesterone III Cal Check 5 (K150955) | Roche Diagnostics | 2015-05-01 |
| IMMULITE IGF Control Module, IMMULITE Gastrin Control Module (K150132) | Siemens Healthcare Diagnostics | 2015-04-13 |
| IDS-iSYS CTX-I Calibration Verifiers (K143324) | Immunodiagnostic Systems , Ltd. | 2015-03-30 |
| IMMULITE® 2000 Calcitonin Calibration Verification Material , IMMULITE® 2000 Prostatic Acid Phosphatase (PAP) Calibration Verification Material (K143373) | Siemens Healthcare Diagnostics, Inc. | 2015-02-26 |
| IMMULITE 2000 Androstenedione Calibration Verification Material, IMMULITE 2000 Troponin I Calibration Verification Material (K143636) | Siemens Healthcare Diagnostics, Inc. | 2015-02-25 |
| ADVIA Centaur IgE Master Curve Material (K143680) | Siemens Healthcare Diagnostics, Inc. | 2015-01-27 |
| IMMULITE 2000 CEA Calibration Verification Material (K143639) | Siemens Healthcare Diagnostics | 2015-01-23 |
| Audit MicroControls Linearity LQ Cystatin-C (K143571) | Aalto Scientific, Ltd. | 2015-01-23 |
| IMMULITE 2000 Albumin Calibration Verification Material, IMMULITE 2000 Myoglobin Calibration Verification Material (K143504) | Siemens Healthcare Diagnostics, Inc. | 2015-01-14 |
| IMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE 2000 IGFBP-3 Calibration Verification Material (K143352) | Siemens Healthcare Diagnostics, Inc. | 2014-12-24 |
| ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur Ferritin Master Curve Material (K143376) | Siemens Healthcare Diagnostics, Inc. | 2014-12-23 |
| Elecsys Estradiol III Calcheck (K143284) | Roche Diagnostics | 2014-12-16 |
| AIA-PACK C-Peptide Control Set (K143296) | Tosoh Bioscience, Inc. | 2014-12-16 |
| ADIVA Centaur Prolactin Master Curve Material (MCM), ADIVA Centaur Cortisol Master Curve Material (MCM) (K143194) | Siemens Healthcare Diagnostics, Inc. | 2014-12-05 |
| Audit MicroControls Linearity FD Unsaturated Iron Binding Capacity (K143026) | Aalto Scientific, Ltd. | 2014-11-21 |
| IMMULITE 2000 Beta-2 Microglobulin Calibration Verification Material, IMMULITE 2000 High Sensitivity CRP Calibration Verification Material (K142878) | Siemens Healthcare Diagnostics, Inc. | 2014-10-30 |
| ADVIA Centaur C-peptide (CpS) Master Curve Material (MCM), ADVIA Centaur Insulin (IRI) Master Curve Material (MCM) (K142864) | Siemens Healthcare Diagnostics, Inc. | 2014-10-29 |
| IMMULITE 2000 LH Calibration Verification Material (CVM), IMMULITE 2000 Free T3 Calibration Verification Material (CVM), IMMULITE 2000 Gastrin Calibration Verification Material (CVM) (K142811) | Siemens Healthcare Diagnostics, Inc. | 2014-10-29 |
| ELECSYS ESTRADIOL III CALCHECK 5 (K142127) | Roche Diagnostics | 2014-09-05 |
| IMMULTE 2000 RUBELLA QUANTITATIVE IGG CALIBRATION VERIFICATION MATERIAL (K141772) | Siemens Healthcare Diagnostics, Inc. | 2014-08-19 |
| IMMULITE 2000; CORTISOL CALIBRATION VERIFICATION MATERIAL, FOLIC ACID CALIBRATION VERIFICATION MATERIAL, VITAMIN B12 CAL (K141444) | Siemens Healthcare Diagnostics, Inc. | 2014-07-09 |
| IMMULITE 2000 FREE PSA CALIBRATION VERIFICATION MATERIAL (K133816) | Siemens Healthcare Diagnostics, Inc. | 2014-06-24 |
| IMMULITE: 2000 FREE T4 CALIBRATION VERIFICATION MATERIAL, 2000 IGF-I CALIBRATION VERIFICATION MATERIAL, 2000 PROLACTIN C (K140818) | Siemens Healthcare Diagnostics, Inc. | 2014-05-01 |
| IMMULITE 2000: C-PEPTIDE CALIBRATION VERIFICATION MATERIAL, SHBG CALIBRATION VERIFICATION MATERIAL, TOTAL TESTOSTERONE C (K140541) | Siemens Healthcare Diagnostics, Inc. | 2014-04-01 |
| ADVIA CENTAUR VITAMIN B12 MASTER CURVE MATERIAL, TOTAL HCG MASTER CURVE MATERIAL, AND TESTOSTERONE MASTER CURVE MATERIAL (K140505) | Siemens Healthcare Diagnostics, Inc. | 2014-03-31 |
| ELECSYS PRECICONTROL TS (K140534) | Roche Diagnostics | 2014-03-27 |
| ADVIA CENTAUR TNI-ULTRA MASTER CURVE MATERIAL (MCM), ADVIA CENTAUR DIGOXIN MASTER CURVE MATERIAL (MCM) (K140267) | Siemens Healthcare Diagnostics, Inc. | 2014-03-10 |
| IMMULITE 2000 DHEA-SO4; THIRD GENERATION TSH AND INTACT PTH CALIBRATION VERIFICATION MATERIAL (K140258) | Siemens Healthcare Diagnostics, Inc. | 2014-03-05 |
| VALIDATE FERRITIN CALIBRATION VERIFICATION/ LINEARITY TEST KIT (K133550) | Maine Standards Company, LLC | 2014-02-05 |
| FDI LEVEL I AND LEVEL II GLUCOSE CONTROLS FOR THE EMBRACE NO CODE (K133197) | Fujirebio Diagnostics,Inc. | 2014-01-17 |
| IMMULITE 2000 AFP, BR-MA, AND OM-MA CALIBRATION VERIFICATION MATERIAL (K132739) | Siemens Healthcare Diagnostics, Inc. | 2014-01-14 |
| ELECSYS CK-MB CALCHECK 5 (K133284) | Roche Diagnostics | 2013-11-22 |
| IMMULITE 2000; 3GALLERGY SPECIFIC IGE CONTROL VERIFICATION MATERIAL (CVM), TOTAL IGE CONTROL VERIFICATION MATERIAL (CVM) (K133122) | Siemens Healthcare Diagnostics, Inc. | 2013-10-30 |
| IMMULITE 2000; TOTAL T3 CALIBRATION VERIFICATION MATERIAL, TOTAL T4 CALIBRATION VERIFICATION MATERIAL, TOTAL TBG CALIBRA (K133124) | Siemens Healthcare Diagnostics, Inc. | 2013-10-25 |
| RIGHTEST CONTROL SOLUTION (K133003) | Bionime Corporation | 2013-10-24 |
| IMMULITE 2000; HCG CALIBRATION VERIFICATION MATERIAL, INSULIN CALIBRATION VERIFICATION MATERIAL, PYRILINKS-D CALIBRATION (K133128) | Siemens Healthcare Diagnostics, Inc. | 2013-10-22 |
| IMMULITE 2000 ACTH CALIBRATION VERIFICATION MATERIAL (K131662) | Siemens Healthcare Diagnostics, Inc. | 2013-10-10 |
| IMMULITE 2000 ANTI-TG AB CALIBRATION VERIFICATION MATERIAL, IMMULITE 2000 ANTI-TPO AB CALIBRATION VERIFICATIN MATERIAL (K132391) | Siemens Helathcare Diagnostics, Inc. | 2013-09-20 |
| IMMULITE 2000 PSA CALIBRATION VERIFICATION MATERIAL (K131536) | Siemens Healthcare Diagnostics, Inc. | 2013-08-12 |
| HBA1C CONTROL, LEVEL 1 AND LEVEL 2 (K131999) | Randox Laboratories, Ltd. | 2013-07-26 |
| ALDOLASE CONTROLS LEVEL 2, AND ALDOLASE CONTROL LEVEL 3 (K131776) | Randox Laboratories, Ltd. | 2013-07-18 |
| VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406 (K123127) | Maine Standards Co. | 2013-06-14 |
| GLUCOSE METER-CHECK SOLUTION FOR TAIDOC (K131136) | Bionostics, Inc. | 2013-05-31 |
| AUDIT MICROCV VITAMIN D LINEARITY SET (K130764) | Aalto Scientific, Ltd. | 2013-04-26 |
| AUDIT MICROCV BETA-HYDROXYBUTYRIC ACID LINEARITY SET (K130157) | Aalto Scientific, Ltd. | 2013-03-19 |
| IMMULITE 1000 THIRD GENERATION PSA CALIBRATION VERIFICATION MATERIAL (K122534) | Siemens Healthcare Diagnostics, Inc. | 2013-03-14 |
| GLUCOSE METER-CHECK SOLUTION FOR ROCHE ACCU-CHEK (K123851) | Bionostics, Inc. | 2013-02-14 |
| GLUCOSE METER-CHECK SOLUTION FOR BAYER (K123966) | Bionostics, Inc. | 2013-01-25 |
| FDI GLUCOSE CONTROL SOLUTION FOR USE WITH ACCU-CHEK AVIVA (K123612) | Fujirebio Diagnostics,Inc. | 2013-01-17 |
| LIQUIDCHEK DIABETES CONTROL; LEVEL 1, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK (K123798) | Bio-Rad Laboratories | 2013-01-09 |
| ELECSYS CA 15-3 II CALCHECK 5 (K122242) | Roche Diagnostics | 2012-12-05 |
| ELECSYS HSV-2 IGG IMMUNOASSAY (K121895) | Roche Diagnostics | 2012-08-24 |
| IDS-ISYS IGF-I CALIBRATION VERIFIERS (K122141) | Immunodiagnostic Systems , Ltd. | 2012-08-07 |
| RANDOX MICROALBUMIN CONTROL LEVEL 1 AND CONTROL LEVEL 2 (LIQUID) (K121746) | Randox Laboratories, Ltd. | 2012-07-11 |
| RANDOX CYSTATIN C CONTROL LEVEL 2 RANDOX CYSTATIN C CONTROL LEVEL 3 (K121588) | Randox Laboratories, Ltd. | 2012-06-20 |
| CONE-TROL HEMOGLOBIN A1C CONTROL SET (K121534) | Cone Bioproducts | 2012-06-20 |
| BETA HCG CONTROL LEVEL 1 BETA HCG CONTROL LEVEL 2 BETA HCG CONTROL LEVEL 3 BETA HCG CALIBRATION VERIFICATION CONTROLS LE (K121237) | Cliniqa Corporation | 2012-05-18 |
| ELECSYS LH CALCHECK 5 (K121279) | Roche Diagnostics | 2012-05-10 |
| COMPLETE D 25-OH VITAMIN D CONTROL (K113177) | Quantimetrix Corp. | 2012-05-10 |
| LOCI CARDIAC TROPONIN-I CONTROL (LOW), LCTNI CON L (K121084) | Siemens Healthcare Diagnostics, Inc. | 2012-05-09 |
| ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEMS (K112653) | ACON Laboratories, Inc. | 2012-04-09 |
| IDS-ISYS IGFBP-3 CONTROL SET, IDS-ISYS HUMAN GROWTH HORMONE (HGH) CALIBRATION VERIFIERS, AND IDS-ISYS IGFBP-3 CAL... (K111938) | Immunodiagnostic Systems , Ltd. | 2012-02-14 |
| AUDIT MICROCV T-UPTAKE LINEARITY (K112143) | Aalto Scientific, Ltd. | 2012-01-31 |
| GLUCOSE METER-CHECK SOLUTION FOR INFOPIA (K113764) | Bionostics, Inc. | 2012-01-30 |
| VALIDATE VIT D CALIBRATION VERIFICATION/ LINEARITY TEST KIT (K113524) | Maine Standards Co. | 2012-01-27 |
| GLUCOSE METER-CHECK CONTROL FOR NIPRO TRUERESULT (K112352) | Bionostics, Inc. | 2011-12-23 |
| ACCESS HYBRITECH P2PSA QC ON THE ACCESS IMMUNOASSAY SYSTEMS (K112603) | Beckman Coulter, Inc. | 2011-11-04 |
| ELECSYS T4 CALCHECK 5 (K112528) | Roche Diagnostics Corporation | 2011-10-18 |
| CVM, UNCONJUGATED ESTRIOL (UE3) CALIBRATION VERIFICATION MATERIAL (K110061) | Siemens Healthcare Diagnostics | 2011-09-21 |
| GLUCOSE METER-CHECK CONTROL SOLUTION FOR AGAMATRIX WAVESENSE (K112356) | Bionostics, Inc. | 2011-09-19 |
| ELECSYS MYOGLOBIN CALCHECK 5 (K112113) | Roche Diagnostics | 2011-09-14 |
| IDS-ISYS CTX-1 (CROSSLAPS) CALIBRATION VERIFIERS, IDS-ISYS 25 HYDROXY VITAMIN D CALIBRATION VERIFIERS, AND IDS-ISYS... (K111650) | Immunodiagnostic Systems , Ltd. | 2011-09-06 |
| ELECSYS N-MID OSTEOCALCIN CALCHECK 5 (K112104) | Roche Diagnostics | 2011-08-25 |
| ELECSYS T3 CALCHECK 5 (K111552) | Roche Diagnostics | 2011-07-21 |
| ELECSYS SHBG CALCHECK 5 (K111349) | Roche Diagnostics | 2011-06-09 |
| FUJIREBIO DIAGNOSTICS VITAMIN D CONTROL (K110641) | Fujirebio Diagnostics,Inc. | 2011-05-27 |
| DROPPER A1C DIABETES CONTROL (K103744) | Quantimetrix Corp. | 2011-05-12 |
| ELECSYS PROLACTIN II CALCHECK 5 (K110613) | Roche Diagnostics | 2011-05-12 |
| IMMULITE/IMMULITE 1000 PROGESTERONE CALIBRATION VERIFICATION (CVM) (K103683) | Siemens Healthcare Diagnostics | 2011-04-28 |
| FDI GLUCOSE CONTROL SOLUTION FOR AVIVA (K110436) | Fujirebio Diagnostics,Inc. | 2011-04-20 |
| IDS-ISYS IFG-I CONTROL SET (K110412) | Immunodiagnostic Systems , Ltd. | 2011-03-16 |
| LIFESCAN ONETOUCH SELECT / ULTRA / VITA GLUCOSE CONTROL SOLUTION (K103553) | Bionostics, Inc. | 2011-02-10 |
| FDI GLUCOSE CONTROL SOLUTION FOR FREESTYLE (K103450) | Fujirebio Diagnostics,Inc. | 2011-01-25 |
| ELECSYS DHEA-S CALCHECK 5 (K103402) | Roche Diagnostics | 2011-01-07 |
| AUDIT MICROCV HOMOCYSTEINE LINEARITY SET, MODEL 704M-5 (K100715) | Aalto Scientific, Ltd. | 2010-12-23 |
| AUDIT MICROCV HS-CRP LINEARITY SET (K101427) | Aalto Scientific, Ltd. | 2010-12-23 |
| PRECICONTROL HBA1C NORM; PRECICONTROL HBA1C PATH (K103099) | Roche Diagnostics | 2010-12-06 |
| ENHANCED ESTRADIOL (EE2) MASTER CURVE MATERIAL (K102904) | Siemens Healthcare Diagnostics | 2010-11-23 |
| ELECSYS PTH CALCHECK 5 (K103162) | Roche Diagnostics | 2010-11-18 |
| ELECSYS CA 125 II CALCHECK 5 (K102086) | Roche Diagnostics | 2010-11-01 |