| Multichem IA Plus (K162530) | Techno-Path Manufacturing | 2017-03-31 |
| Audit MicroControls Linearity FD Tumor Markers II (K163629) | Aalto Scientific, Ltd. | 2017-03-10 |
| Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak (K163015) | Bio-Rad Laboratories | 2017-01-10 |
| VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit (K153712) | Radiometer America, Inc. | 2016-01-28 |
| Liquichek Cardiac Markers Plus Control LT (K150300) | Bio-Rad Laboratories | 2015-12-11 |
| VALIDATE Anemia Calibration Verification/ Linearity Test Kit (K142964) | Maine Standards Company, LLC | 2015-04-30 |
| Liquichek Maternal Serum II Control (K143379) | Bio-Rad Laboratories | 2015-03-13 |
| Audit MicroControls Linearity FD Tumor Markers II (K143573) | Aalto Scientific, Ltd. | 2015-01-16 |
| LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3. (K140971) | Randox Laboratories Limited | 2014-12-08 |
| Audit MicroControls Linearity LQ Special Diabetes (K142978) | Aalto Scientific, Ltd. | 2014-11-20 |
| ABX PENTRA MICRO ALB CONTROL L/H (K133676) | HORIBA ABX SAS | 2014-07-11 |
| LIQUICHEK TUMOR MARKER CONTROL (K141073) | Bio-Rad Laboratories | 2014-06-23 |
| RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND IMMUNOASSAY PREMIUM PLUS TRI-LEVEL CONTROL (K140522) | Randox Laboratories Limited | 2014-05-22 |
| LIQUICHEK CARDIAC TROPONINS CONTROL, LEVELS 1,2 AND 3, TRILEVEL/MINIPAK (K140916) | Bio-Rad Laboratories | 2014-05-06 |
| LIQUICHEK IMMUNOLOGYCONTROL-LEVEL 1,LEVEL 2, LEVEL 3, MINIPAK (K140764) | Bio-Rad Laboratories | 2014-04-25 |
| LYPHOCHEK ALLERGEN SIGE CONTROL, NEGATIVE, LYPOCHEK ALLERGEN SIGE CONTROL, NEGATIVE MINIPAK, LYPHOCHEK ALLERGEN SIGE CO (K134013) | Bio-Rad Laboratories | 2014-04-24 |
| RANDOX AMMONIA ETHANOL CONTROL LEVELS 1, 2 AND LEVEL 3 (K140393) | Randox Laboratories Limited | 2014-03-25 |
| LYPOCHEK SPECIALTY IMMUNOASSAY CONTROL (K133960) | Bio-Rad Laboratories | 2014-01-22 |
| LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-LEVEL I, LIQUICHEK IMMUNOASSAY (K132227) | Bio-Rad Laboratories | 2013-10-25 |
| RANDOX CSF CONTROLS LEVELS 2 AND 3 (K132156) | Randox Laboratories, Ltd. | 2013-10-23 |
| MULTICHEM S PLUS / S PLUS (ASSAYED) (K132751) | Techno-Path Manufacturing , Ltd. | 2013-10-22 |
| MULTICHEM U (K131993) | Techno-Path Manufacturing , Ltd. | 2013-10-15 |
| V8 SP NORMAL CONTROL, ABNORMAL CONTROL (K131479) | Helena Laboratories | 2013-10-07 |
| MULTICHEM P (K131992) | Techno-Path Manufacturing , Ltd. | 2013-09-25 |
| MULTICHEM IA AND IA PLUS (K132091) | Techno-Path Manufacturing , Ltd. | 2013-09-20 |
| EUROTROL GAS-ISE HCT QC AND EUROTROL GAS-ISE HCT LVM (K131595) | Eurotrol B.V. | 2013-07-26 |
| RANDOX SPECIALITY CONTROL (I) LEVELS 1, 2 AND 3 (K130337) | Randox Laboratories Limited | 2013-06-19 |
| LIQUICHEK PEDIATRIC CONTROL, LEVEL 1; LIQUICHEK PEDIATRIC CONTOL, LEVEL 2; LIQUICHEK PEDIATRIC CONTROL, BILEVEL MINIPAK (K130963) | Bio-Rad Laboratories, Inc. | 2013-05-06 |
| AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET (K130762) | Aalto Scientific, Ltd. | 2013-04-29 |
| MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS LEVEL 2, MISSION C (K124009) | Diamond Diagnostics, Inc. | 2013-04-17 |
| LIQUICHEK IMMUNOLOGY CONTROL, LEVEL 1,2,3, TRILEVEL MINIPAK (K130761) | Bio-Rad Laboratories | 2013-04-12 |
| FASTPACK CONTROL KIT (K123725) | Qualigen, Inc. | 2013-03-08 |
| LIQUID ASSAYED MULTIQUAL PREMIUM (K130162) | Bio-Rad Laboratories | 2013-03-01 |
| LIQUICHEK SPINAL FLUID CONTROL LEVEL 1, LIQUICHEK SPINAL FLUID CONTROL LEVEL 2, LIQUICHEK SPINAL FLUID CONTROL MINIPAK (K123775) | Bio-Rad Laboratories | 2013-01-31 |
| LIQUIDCHEK CARDIAC MARKERS PLUS CONTROL LT; LEVEL 1C, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK (K123663) | Bio-Rad Laboratories | 2012-12-27 |
| RANDOX IMMUNOASSAY SPECIALITY CONTROL (II), LEVEL 1, LEVEL 2 AND LEVEL 3 (K121603) | Randox Laboratories, Ltd. | 2012-11-20 |
| LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 1 MODEL 271, LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 2 MODEL 272, LIQUICHEK ETHA (K123198) | Bio-Rad Laboratories | 2012-11-20 |
| LIQUICKEK IMMUNOASSAY PLUS CONTROL, LEVEL 1 MODEL 267, LIQUICHEK IMMUNOASSAY PLUS CONTROL, LEVEL 2 MODEL 268, LIQUICHEK (K122838) | Bio-Rad Laboratories | 2012-10-17 |
| RANDOX MATERNAL CONTROL, LEVELS 1, 2 AND 3 (K113720) | Randox Laboratories, Ltd. | 2012-09-20 |
| THERMO SCIENTIFIC MAS OMNI-CARDIO (K122291) | Microgenics Corporation | 2012-08-31 |
| CONE-TROL LIQUID CHEMISTRY CONTROLS (K121759) | Cone Bioproducts | 2012-07-24 |
| LIQUICHEK URINE CHEMISTRY CONTROL (K121794) | Bio-Rad, Diagnostics Grp. | 2012-07-11 |
| EUROTROL GAS-ISE METABOLITES (K121468) | Eurotrol B.V. | 2012-06-22 |
| AUDIT MICROLQ SPINAL FLUID CONTROL (K112742) | Aalto Scientific, Ltd. | 2012-06-15 |
| AUDIT MICROCV URINE/FLUIDS CHEMISTRY LINEARITY (K111964) | Aalto Scientific, Ltd. | 2012-03-02 |
| AUDIT(R) MICROLQ(TM) SERUM PROTEIN CONTROL (K112705) | Aalto Scientific, Ltd. | 2012-01-24 |
| RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 3 (K110534) | Randox Laboratories Limited | 2012-01-23 |
| RANDOX LIQUID IMMUNOASSAY PREMIUM CONTROLS, LEVEL 1, LEVEL2, LEVEL 3 AND TRI LEVEL (K112337) | Randox Laboratories, Ltd. | 2011-12-01 |
| IT/IF CONTROL (K101863) | Sebia | 2011-11-07 |
| THERMO SCIENTIFIC MAS OMNI-CORE (K110738) | Microgenics Corporation | 2011-11-03 |
| RANDOX LIQUID URINE CONTROL LEVELS 2 AND 3 (K110904) | Randox Laboratories, Ltd. | 2011-09-30 |
| ELITECH CLINICAL SYSEMS ISE CONTROL 1 AND 2 (K111996) | Elitechgroup | 2011-09-14 |
| ELECSYS PRECICONTROL VARIA 3 (K111506) | Roche Diagnostics | 2011-07-08 |
| VALIDATE (R) GC3 CALIBRATION VERIFICATION / LINEARITY TEST KIT (K110880) | Maine Standards Company, LLC | 2011-07-05 |
| THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO (K110616) | Microgenics Corp. | 2011-06-29 |
| VITAL SERUM CONTROLS (K111063) | Vital Diagnostics (Manufacturing) Ptyltd | 2011-06-28 |
| AUDIT MICROCV IMMUNOASSAY LINEARITY SET (K103601) | Aalto Scientific, Ltd. | 2011-06-10 |
| MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, LEVEL 2, DUAL LEVEL (K103364) | Diamond Diagnostics, Inc. | 2011-05-06 |
| MSC LIPID CONTROL (K103271) | Maine Standards Co. | 2011-01-25 |
| AUDIT MICROCV PROTEIN LINEARITY SET (K101216) | Aalto Scientific, Ltd. | 2011-01-14 |
| AUDIT MICROCV CARDIAC MARKERS LINEARITY SET (K102617) | Aalto Scientific, Ltd. | 2011-01-10 |
| LIPID CONTROLS; MULTI- ANALYTE CONTROL; MULTI-ANALYTE CALIBRATION VERIFICATION MATERIALS (K102700) | Alere, San Diego, Dba Biosite INcorporated, Dba IN | 2010-12-21 |
| FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL MODEL 108-20 (K101809) | Fujirebio Diagnostics,Inc. | 2010-10-05 |
| LIQUID ASSAYED MULTIQUAL 1, LIQUID ASSAYED MULTIQUAL 2, LIQUID ASSAYED MULTIQUAL 3, LIQUID ASSAYED MULTIQUAL MINIPAK (K100727) | Bio-Rad, Diagnostics Grp. | 2010-09-14 |
| AUDIT MICROCV AMMONIAN/ETHANOL LINEARITY SET, MODEL K712M-5 (K100718) | Aalto Scientific, Ltd. | 2010-09-03 |
| PRECICONTROL CLINCHEM MULTI 1 AND 2 (K102016) | Roche Diagnostics | 2010-09-01 |
| AUDIT MICROCV RF/CRP LINEARITY SET (K101226) | Aalto Scientific, Ltd. | 2010-08-31 |
| ELECSYS PRECICONTROL MULTIMARKER (K102157) | Roche Diagnostics | 2010-08-27 |
| NOVA MAX PLUS GLOCOSE AND B-KETONE CONTROL SOLUTION-MID, HIGH (K101633) | Nova Biomedical Corp. | 2010-08-27 |
| MISSION CLINICHECK ASSAYED CHEMISTRY CONTROL, LEVEL 1&2, MISSION CLINICAL CALIBRATOR (K093492) | Diamond Diagnostics, Inc. | 2010-03-19 |
| MISSION TRINITY R (LEVEL 1) (LEVEL 2) (LEVEL 3), (LEVEL 1,2,3) (K093384) | Diamond Diagnostics, Inc. | 2010-03-10 |
| TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SET (K093032) | Biosite Incorporated | 2009-11-13 |
| ELECSYS PRECICONTROL THYROAB (K092320) | Roche Diagnostics | 2009-11-03 |
| THERMO SCIENTIFIC MAS CHEM TRAK & MONI TROL H LIQUID ASSAYED CHEMISTRY CONTROL, MODEL, CHA, CHU, M5155, M5158 (K092051) | Microgenics Corp. | 2009-09-21 |
| ELECSYS PRECICONTROL UNIVERSAL (K090541) | Roche Diagnostics | 2009-07-02 |
| VALIDATE GC1, GC2, GC3 AND GC4 CALIBRATION VERIFICATION/LINEARITY TEST SET (K091225) | Maine Standards Co. | 2009-06-25 |
| CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 3 (K083554) | Cliniqa Corporation | 2009-04-21 |
| VALIDATE CM2 CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 402 (K090475) | Maine Standards Co. | 2009-04-16 |
| VALIDATE THYROID CALIBRATION VERIFICATION TEST SET, MODEL 901 (K083891) | Maine Standards Co. | 2009-03-23 |
| AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET, MODEL K707M-5 (K082714) | Aalto Scientific, Ltd. | 2008-11-19 |
| AUDIT MICROCV TUMOR MARKERS LINEARITY SET, MODEL K719M-5 (K082717) | Aalto Scientific, Ltd. | 2008-10-30 |
| CLINIQA LIQUID QC URINE CHEMISTRY CONTROLS, LEVELS 1 AND 2 (K082107) | Cliniqa Corporation | 2008-09-17 |
| LYPHOCHEK TUMOR MARKET PLUS CONTROL LEVEL 1, 2 AND 3 AND MINIPAK (K082036) | Bio-Rad Laboratories | 2008-09-08 |
| MSC LIPID CONTROL (K082067) | Maine Standards Co. | 2008-08-22 |
| CLINIQA LIQUID QC COMPLETE CARDIAC MARKER CONTROL, LEVELS 1,2, AND 3; CARDIAC MARKER CONTROL-LOW, AND LINICAL CARDIAC (K080973) | Cliniqa Corporation | 2008-06-02 |
| QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945 (K073080) | Bio-Rad Laboratories | 2008-01-24 |
| LIQUICHEK MICROALBUMIN CONTROL LEVEL 1, LEVEL 2, CONTROL MINIPAK (K072835) | Bio-Rad, Diagnostics Grp. | 2007-12-11 |
| TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5 (K072892) | Biosite Incorporated | 2007-12-07 |
| VALIDATE SP1 CALIBRATION VERIFICATION/LINEARITY TEST SET, MODEL 601 (K072246) | Maine Standards Co. | 2007-09-14 |
| DIMENSION VISTA PROTEIN 1 CALIBRATOR, PROTEIN1 CONTROL L,M,H (K071980) | Dade Behring, Inc. | 2007-09-11 |
| LIQUICHEK TUMOR MARKER CONTROL (K071675) | Bio-Rad Laboratories | 2007-07-03 |
| SMS GLUCOSE CONTROL, MODEL 2120059 (K071433) | Specialty Medical Supplies | 2007-06-28 |
| CLINIQA LIQUID QC UNASSAYED AND ASSAYED GENERAL CHEMISTRY CONTROL LEVELS 1, 2, & 3 (K070741) | Cliniqa Corporation | 2007-05-04 |
| AMMONIA/ALCOHOL CONTROL SET (K070504) | Pointe Scientific, Inc., | 2007-04-11 |
| TDM CONTROL SET, MODEL CAT# 04521536 (K070200) | Roche Diagnostics Corp. | 2007-03-19 |
| AUDIT MICROCV LIPIDS LINEARITY SET (LOW) (K070223) | Aalto Scientific, Ltd. | 2007-03-13 |
| COBAS INTEGRA CERULOPLASMIN (K062379) | Roche Diagnostics Corp. | 2007-01-31 |
| MISSION TRINITY B (K062674) | Diamond Diagnostics, Inc. | 2006-12-01 |
| CARDIAC MARKERS CONTROL AND CALIBRATION VERIFICATION CONTROL SET (K062593) | Compass Bioscience | 2006-11-22 |
| CLINIQA LIQUID QC CARDIAC MARKER CONTROL SP, LEVELS 1,2, &3 (K062916) | Cliniqa Corporation | 2006-10-23 |