| ELECSYS IGE CALCHECK 5 (K102269) | Roche Diagnostics | 2010-10-07 |
| ELECSYS CA 19-9 CALCHECK 5 (K101365) | Roche Diagnostics Corp. | 2010-10-05 |
| ELECSYS CEA CALCHECK 5 (K101856) | Roche Diagnostics | 2010-10-05 |
| FDI GLUCOSE CONTROL SOLUTIONS (K102260) | Fujirebio Diagnostics,Inc. | 2010-09-24 |
| ELECSYS FERRITIN CALCHECK 5 (K102267) | Roche Diagnostics | 2010-09-10 |
| ELECSYS DIGOXIN CALCHECK 5 (K102044) | Roche Diagnostics | 2010-08-31 |
| FORA CONTROL SOLUTION, TAIDOC CONTROL SOLUTION (K093724) | Taidoc Technology Corporation | 2010-07-29 |
| ELECSYS INSULIN CALCHECK 5 (K101075) | Roche Diagnostics Corp. | 2010-06-11 |
| AUDIT MICROCV ASO LINEARITY SET, MODEL K721M-5 (K100750) | Aalto Scientific, Ltd. | 2010-05-21 |
| ELECSYS FOLATE III CALCHECK 5 (K094031) | Roche Diagnostics | 2010-04-27 |
| ELECSYS C-PEPTIDE CALCHECK 5 (K100810) | Roche Diagnostics | 2010-04-26 |
| SMART HBA1C ASSAY KIT, MODEL DZ168B-POC, SMART HBA1C ASSAY CONTROL KIT, MODEL DZ168B-CON, SMART HBAC1C ANALYZER (K092911) | Diazyme Laboratories | 2010-04-26 |
| ELECSYS TSH CALCHECK 5 (K093836) | Roche Diagnostics | 2010-04-15 |
| CONTREX PLUS LOW CONTROL SOLUTION (K100747) | Apex BioTechnology Corp. | 2010-04-14 |
| ELECSYS TROPONIN I CALCHECK 5 (K100594) | Roche Diagnostics | 2010-04-01 |
| ELECSYS CK-MB CALCHECK 5 (K093582) | Roche Diagnostics | 2010-03-29 |
| ELECSYS TROPONIN T CALCHECK 5 (K092848) | Roche Diagnostics Corp. | 2010-03-19 |
| ELECSYS HCG STAT CALCHECK 5 (K093700) | Roche Diagnostics Corp. | 2010-03-04 |
| ELECSYS PROBNP II CALCHECK 5 (K092169) | Roche Diagnostics | 2009-12-16 |
| LIAISON N-TACT PTH CALIBRATION VERIFIERS MODEL 310913 (K093498) | DiaSorin, Inc. | 2009-12-14 |
| MAS AND MINI-TROL PTH CONTROL (K092749) | Microgenics Corporation | 2009-12-03 |
| ADVIA CENTAUR CYCLOSPORINE MASTER CURVE MATERIAL (K092993) | Siemens Healthcare Diagnostics | 2009-11-20 |
| ELECSYS HCG+B CALCHECK 5 (K092168) | Roche Diagnostics | 2009-11-16 |
| ELECSYS TOXO IGG CALCHECK 5 (K092888) | Roche Diagnostics Corp. | 2009-11-10 |
| OMNIS HEALTH EMBRACE GLUCOSE CONTROL SOLUTION (K091914) | Bionostics, Inc. | 2009-11-06 |
| ELECSYS RUBELLA IGGA CALCHECK 5 (K092585) | Roche Diagnostics | 2009-10-30 |
| ELECYS ANTI-CCP CALCHECK (K091601) | Roche Diagnostics Corp. | 2009-09-25 |
| LIAISON 25 OH VITAMIN D TOTAL CALIBRATION VERIFIERS, MODEL: 310603 (K090104) | DiaSorin, Inc. | 2009-09-09 |
| FDI GLUCOSE CONTROL LEVELS 1, 2 AND 3 (K092645) | Fujirebio Diagnostics,Inc. | 2009-09-05 |
| ADVIA CENTAUR DHEAS MASTER CURVE MATERIALS (K091123) | Siemens Healthcare Diagnostics | 2009-08-14 |
| ABT GLUCOSE CONTROL SOLUTION LEVEL 1,2,3 MODEL, 2120083,2120086, 2120087 (K091460) | American Biological Technologies, Inc. | 2009-08-06 |
| ABT GLUCOSE CONTROL SOLUTION, MODEL: 2120089 (K090943) | American Biological Technologies, Inc. | 2009-05-27 |
| ELECSYS RUBELLA IGG CALCHECK (K090311) | Roche Diagnostics | 2009-05-05 |
| ABT GLUCOSE CONTROL SOLUTION, MODEL 2120090 (K090854) | American Biological Technologies, Inc. | 2009-04-16 |
| ELECSYS TOXO IGG CALCHECK (K083655) | Roche Diagnostics | 2009-02-12 |
| ABT GLUCOSE CONTROL SOLUTION (K083549) | American Biological Technologies, Inc. | 2008-12-22 |
| RNA MEDICAL GLUCOSE AND B-KETONE CALIBRATION VERIFICATION CONTROLS (K081478) | Bionostics, Inc. | 2008-10-06 |
| GLUCOSE METER-CHECK CONTROL SOLUTION FOR BAYER ASCENSIA BLOOD GLUCOSE METER, MODEL: MC002 (K082395) | Bionostics, Inc. | 2008-09-18 |
| ELECSYS ANTI-TSHR CALCHECK (K080643) | Roche Diagnostics | 2008-08-22 |
| FDTX GLUCOSE CONTROL SOLUTION (K081915) | Fujirebio Diagnostics Texas, Inc. | 2008-08-08 |
| AB-TROL AND PRIVATE LABEL GLUCOSE CONTROL SOLUTION (K080273) | Fujirebio Diagnostics Texas, Inc. | 2008-08-08 |
| GLUCOSE METER-CHECK CONTROL SOLUTION FOR ROCHE ACCU-CHEK (K081403) | Bionostics, Inc. | 2008-07-25 |
| ELECSYS PROBNP II CALCHECK (K080147) | Roche Diagnostics Corp. | 2008-02-27 |
| EXTENDSURE LYOPHILIZED HBA1C LINEARITY CONTROLS (K071648) | Canterbury Scientific , Ltd. | 2007-08-22 |
| ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST) ASSAY (K071587) | Inverness Medical Innovations, Inc. | 2007-07-30 |
| SMS MULTI GLUCOSE CONTROL, MODEL 2120049 (K070506) | Medical Specialties Supply Co., Inc. | 2007-04-18 |
| SMS GLUCOSE CONTROL, MODEL 2120061 (K070649) | Spectrum Medical Supply, Inc. | 2007-04-12 |
| FASTPACK TOTAL PSA METHOD VERIFICATION KIT (K062957) | Qualigen, Inc. | 2007-04-02 |
| LIBERTY NORMAL GLUCOSE CONTROL SOLUTION, MODEL 2120045/ HIGH GLUCOSE CONTROL SOLUTION, MODEL 2120047 (K063855) | Liberty Healthcare Group, Inc. | 2007-02-01 |
| PRECINORM CK-MB AND PRECIPATH CK-MB CONTROLS (K062972) | Roche Diagnostics Corp. | 2006-10-13 |
| VALIDATE THYROID CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 901 (K062501) | Maine Standards Co. | 2006-09-29 |
| DREW SCIENTIFIC GLYCATED HEMOGLOBIN FIVE LEVEL LINEARITY KIT (K060510) | Drew Scientific , Ltd. | 2006-06-19 |
| LIBERTY NORMAL GLUCOSE CONTROL SOLUTION (K060706) | Liberty Healthcare Group, Inc. | 2006-04-28 |
| HEMOGLOBIN ALC CONTROL (K060570) | Compass Bioscience | 2006-04-13 |
| ALBU TROL, LOW, MODEL 108.001.002; ALBU TROL, HIGH 108.002.002 (K060215) | Eurotrol B.V. | 2006-03-24 |
| LIBERTY GLUCOSE CONTROL SOLUTION (K060481) | Liberty Healthcare Group, Inc. | 2006-03-09 |
| LIBERTY GLUCOSE NORMAL CONTROL SOLUTIONS, MODEL 2120041 (K060426) | Liberty Healthcare Group, Inc. | 2006-03-09 |
| ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB) ASSAY VERIFICATION SET (K060133) | Inverness Medical Innovations, Inc. | 2006-02-16 |
| OXICOM CONTROL (K053327) | Bionostics, Inc. | 2006-01-26 |
| ARCHITECT DHEA-S CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM AND HIGH) (K060027) | Biokit, S.A. | 2006-01-26 |
| LIBERTY GLUCOSE CONTROL, MODEL 2120031 (K052980) | Liberty Healthcare Group, Inc. | 2005-11-30 |
| ROCHE DIAGNOSTICS ELECSYS PROLACTIN II CALCHECK (K053059) | Roche Diagnostics | 2005-11-28 |
| CLINIQA LIQUID QC BILIRUBIN CONTROLS LEVELS 1, 2 & 3; CLINIQA LINICAL BILIRUBIN CALIBRATION VERIFIERS LEVELS A-E (K052679) | Cliniqa Corporation | 2005-11-18 |
| HBA1C LINEARITY SET (K052010) | Cone Bioproducts | 2005-10-04 |
| IRMA TRUPOINT CREATININE CONTROL KIT (K050983) | International Technidyne Corporation | 2005-05-16 |
| RNA1C CONTROL FOR NYCOCARD HBA1C (K050961) | Bionostics, Inc. | 2005-05-13 |
| PREGNANCY-SKREEN (K050328) | Biochemical Diagnostic, Inc. | 2005-03-29 |
| RNA1C HEMOGLOBIN A1C CONTROL FOR BAYER DCA2000 AND DCA2000+ ANALYZER (K050100) | Bionostics, Inc. | 2005-02-25 |
| LIQUICHEK BNP CONTROL (K043584) | Bio-Rad Laboratories, Inc. | 2005-02-08 |
| MODIFICATION TO ROCHE ELECSYS FOLATE II CALCHECK II (K043320) | Roche Diagnostics Corp. | 2004-12-17 |
| LIQUID STABLE HBA1C CONTROL (K043070) | Canterbury Scientific , Ltd. | 2004-12-09 |
| MAS, DADE AND LIQUID ASSAYED DIABETES CONTROL (K042717) | Medical Analysis Systems, Inc. | 2004-11-05 |
| LIQUICHEK ELEVATED CRP CONTROL (K042837) | Bio-Rad | 2004-11-02 |
| DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT (K042448) | General Atomics | 2004-10-29 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS (K042303) | Ortho-Clinical Diagnostics | 2004-09-27 |
| TRACKEASE SMART SYSTEM BLOOD GLUCOSE SYSTEM (K042080) | Home Diagnostics, Inc. | 2004-08-19 |
| ABBOTT IMMUNOASSAY/CLINICAL CHEMISTRY SINGLE ANALYTE QUALITY CONTROL MATERIALS (ASSAYED) AND ABBOTT ESTRADIOL CALIBRATOR (K041687) | Abbott Laboratories | 2004-08-18 |
| INTERLAB MICROCAL SERUM CONTROLS (K041871) | Trouble Shooter Consuling, Inc. | 2004-08-16 |
| ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, M AND H (K041194) | Medical Analysis Systems, Inc. | 2004-08-16 |
| CLINIQA LIQUID QC TDM CONTROLS LEVELS 1,2 & 3/CLINIQA LINICAL TDM CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEM (K041898) | Cliniqa Corporation | 2004-08-16 |
| LINICAL PROTEIN 1 CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU ANALYZERS (K040927) | Cliniqa Corporation | 2004-05-17 |
| WAKO LIPID CONTROL, LEVEL 1 AND LEVEL 2 (K040918) | Wako Chemicals USA, Inc. | 2004-05-17 |
| NOVA GLUCOSE LOW/HIGH LEVEL CONTROL SOLUTIONS (K041016) | Nova Biomedical Corp. | 2004-05-07 |
| RANDOX LIQUID CRP CONTROLS (K040351) | Randox Laboratories, Ltd. | 2004-03-12 |
| R&D GLU-LINE HEMATOLOGY CONTROL (K034048) | R&D Systems, Inc. | 2004-03-10 |
| LINICAL URIC ACID CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU SYSTEMS (K040455) | Cliniqa Corporation | 2004-03-05 |
| A1C-CELLULAR (K040025) | Streck Laboratories, Inc. | 2004-03-02 |
| ELECSYS C-PEPTIDE CALCHECK (K040157) | Roche Diagnostics Corp. | 2004-02-25 |
| AMNISURE FETAL MEMBRANES RUPTURE TEST MODEL FMRT1 (K030849) | N-Dia, Inc. | 2004-02-02 |
| NOVA GLUCOSE CONTROL SOLUTIONS (K033433) | Nova Biomedical Corp. | 2004-01-02 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM CONTROLS (K032993) | Ortho-Clinical Diagnostics, Inc. | 2003-10-31 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC CONTROLS (K033127) | Ortho-Clinical Diagnostics | 2003-10-31 |
| GLUCOSE CONTROL SOLUTION FOR CHDIAGNOSTICS SENOVA, CHDIGNOSTICS SENOVA BLOOD GLUCOSE TEST SYSTEM (K032819) | Bionostics, Inc. | 2003-10-20 |
| I-STAT CARDIAC MARKERS CONTROL LEVEL 1, 2, AND 3; CARDIAC MARKERS CALIBRATION VERIFICATION CONTROL SET (K031873) | I-Stat Corporation | 2003-10-07 |
| ELECSYS PRECICONTROL TROPONIN T (K031990) | Roche Diagnostics Corp. | 2003-08-20 |
| ELECYS SHBG CALCHECK (K031698) | Roche Diagnostics Corp. | 2003-08-20 |
| MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL (K031890) | Medical Analysis Systems, Inc. | 2003-07-16 |
| SAS RSV CONTROL KIT (K030628) | Sa Scientific, Inc. | 2003-03-17 |
| WAKO NEFA LINEARITY SET (K030065) | Wako Chemicals USA, Inc. | 2003-02-11 |
| ELECSYS PROBNP CALCHECK (K020883) | Roche Diagnostics Corp. | 2002-11-29 |