| 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 |
| ABL90 FLEX (K122729) | Radiometer Medical Aps | 2012-11-16 |
| PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM (K113314) | Hmd Biomedical, Inc. | 2012-11-09 |
| ABL90 FLEX (K122642) | Radiometer Medical Aps | 2012-10-26 |
| VITROS CHEMISTRY PRODUCTS ECO2 SLIDES (K120765) | Ortho-Clinical Diagnostics, Inc. | 2012-10-24 |
| LIQUICKEK IMMUNOASSAY PLUS CONTROL, LEVEL 1 MODEL 267, LIQUICHEK IMMUNOASSAY PLUS CONTROL, LEVEL 2 MODEL 268, LIQUICHEK (K122838) | Bio-Rad Laboratories | 2012-10-17 |
| RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORS (K122398) | Siemens Healthcare Diagnostics, Inc. | 2012-10-12 |
| ACCU-CHEK INFORM II BLOOD GLUCOSE MONITORING SYSTEM (K121679) | Roche Diagnostics | 2012-10-11 |
| EPOC CHLORIDE TEST AND EPOC CREATININE TEST (K113726) | Epocal, Inc. | 2012-10-05 |
| ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT (K122757) | Alfa Wassermann Diagnostic Technologies, Inc. | 2012-10-05 |
| ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II (K122858) | Elitechgroup | 2012-10-03 |
| QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY TEST (K112449) | Tianjin New Bay Bioresearch Co., Ltd. | 2012-09-24 |
| RANDOX MATERNAL CONTROL, LEVELS 1, 2 AND 3 (K113720) | Randox Laboratories, Ltd. | 2012-09-20 |
| GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEM (K121224) | Taidoc Technology Corporation | 2012-09-19 |
| TESTOSTERONE TEST SYSTEM; CALIBRATOR; AND QUALITY CONTROL MATERIAL (ASSAYED AND UNASSAYED) (K120009) | Abbott Laboratories | 2012-09-11 |
| ESENSOR RESPIRATORY VIRAL PANEL (K113731) | Clinical Micro Sensors, Inc. | 2012-09-10 |
| VITROS CHEMISTRY PRODUCTS DHDL SLIDES (K120609) | Ortho-Clinical Diagnostics, Inc. | 2012-09-07 |
| TEST, BLOOD GLUCOSE SYSTEM (K120064) | Hmd Biomedical, Inc. | 2012-09-05 |
| AUTO-CHEK BLOOD GLUCOSE MONITORING SYSTEM, METER, TEST STRIP. AUTO-CHECK CONTROL SOLUTION (K121654) | I-Sens, Inc. | 2012-09-05 |
| FLEXLAB 3.6, ACCELERATOR A3600 (K121012) | Inpeco S.P.A. | 2012-08-31 |
| THERMO SCIENTIFIC MAS OMNI-CARDIO (K122291) | Microgenics Corporation | 2012-08-31 |
| VANTERA CLINICAL ANALYZER (K113830) | Liposcience | 2012-08-30 |
| SMARTLYTE ELECTROLYTE ANALYZER (K121040) | Diamond Diagnostics, Inc. | 2012-08-30 |
| DIMENSION VISTA ALKALINE PHOSPHATASE (ALPI) FLEX REAGENT CARTRIDGE DIMENSION VISTA ALKALINE PHOSPHATASE CALIBRATOR (ALPI (K122323) | Siemens Healthcare Diagnostics | 2012-08-28 |
| ACE MAGNESIUM REGENT (K122302) | Alfa Wassermann Diagnostics Technologies, LLC | 2012-08-27 |
| ELECSYS HSV-2 IGG IMMUNOASSAY (K121895) | Roche Diagnostics | 2012-08-24 |
| PROLYTE ELECTROLYTE ANALYZER (K121140) | Diamond Diagnostics, Inc. | 2012-08-22 |
| EON CALCIUM REGENT (K120626) | Vital Diagnostics (Manufacturing) Ptyltd | 2012-08-22 |
| ELITECH CLINICAL SYSTEMS CK NAC SL (K122083) | Elitechgroup | 2012-08-22 |
| CLEVER CHOICE (K120921) | Simple Diagnostics, Inc. | 2012-08-21 |
| TYSONBIO MD100 BLOOD GLUCSE MONITORING ,TYSONBIO MD100 PRO BLOOD GLUCISE MONITORING SYSTEM (K112916) | Tyson Bioresearch, Inc. | 2012-08-21 |
| DIRECT LDL/HDL CHOLESTEROL CALIBRATOR (K122126) | Randox Laboratories Limited | 2012-08-14 |
| ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENT (K113389) | Alfa Wassermann Diagnostic Technologies, Inc. | 2012-08-10 |
| IDS-ISYS IGF-I CALIBRATION VERIFIERS (K122141) | Immunodiagnostic Systems , Ltd. | 2012-08-07 |
| BIOLAND G-423 GLOOD GLUCOSE MONITORING SYSTEM (K113077) | Taidoc Technology Corporation | 2012-08-03 |
| BIONIME RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM650 (K120423) | Bionime Corporation | 2012-08-03 |
| DIAZYME HOMOCYSTEINE POC TEST KIT (K121053) | Diazyme Laboratories | 2012-07-31 |
| EON CHOLESTEROL REAGENT (K120202) | Vital Diagnostics Pty., Ltd. | 2012-07-27 |
| GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEM (K113307) | Hmd Biomedical, Inc. | 2012-07-27 |
| CONTOUR NEXT BLOOD GLUCOSE METER (K121190) | Bayer Healthcare, LLC | 2012-07-26 |
| A/C ENZYMATIC VITAMIN B6 ASSAY (K111260) | Anticancer, Inc. | 2012-07-26 |
| ELECSYS VITAMIN D ASSAY ELECSYS VITAMIN D CALSET ELECSYS PRECICONTROL VARIA 3 ELECSYS VITAMIN D CALCHECK 5 (K113546) | Roche Diagnostics | 2012-07-24 |
| CONE-TROL LIQUID CHEMISTRY CONTROLS (K121759) | Cone Bioproducts | 2012-07-24 |
| DIMENSION ALKALINE PHOSPHATASE FLEX REAGENT CARTRIDGE, DIMENSION ALKALINE PHOSPHATASE CALIBRATOR (K121907) | Siemens Healthcare Diagnostics | 2012-07-23 |
| ACE ALT REAGENT (K113382) | Alfa Wassermann | 2012-07-19 |
| FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS (K112101) | Polymed Therapeutics, Inc. | 2012-07-17 |
| ACE ALBUMIN REAGENT ACE TOTAL PROTEIN REAGENT ACE CALCIUM-ARSENAZO REAGENT ACE PHOSPHORUS U.V. REAGENT (K113374) | Alfa Wassermann Diagnostic Technologies, Inc. | 2012-07-13 |
| HEALTHPRO BLOOD GLUCOSE MONITORING SYSTEM (K113192) | Infopia Co, Ltd. | 2012-07-13 |
| ACE ALKALINE PHOSPHATASE REAGENT, ACE AMYLASE REAGENT, ACE LDH-L REAGENT (K113436) | Alfa Wassermann | 2012-07-12 |
| LIQUICHEK URINE CHEMISTRY CONTROL (K121794) | Bio-Rad, Diagnostics Grp. | 2012-07-11 |
| RANDOX MICROALBUMIN CONTROL LEVEL 1 AND CONTROL LEVEL 2 (LIQUID) (K121746) | Randox Laboratories, Ltd. | 2012-07-11 |
| CARESENS N VOICE BLOOD GLUCOSE MONITORING SYSTEM (K121133) | I-Sens, Inc. | 2012-07-10 |
| AUTOSURE VOICE 3 PLUS BLOOD GLUCOSE MONITORING SYSTEM (K120649) | Apex BioTechnology Corp. | 2012-07-06 |
| ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT-C, ACE-TRISLYCERIDES REAGENT (K113262) | Alfa Wassermann Diagnostic Technologies, Inc. | 2012-07-03 |
| ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT (K113435) | Alfa Wassermann | 2012-07-02 |
| CONTOUR NEXT USB BLOOD GLUCOSE MONITORING SYSTEM (K121087) | Bayer Healthcare | 2012-06-28 |
| EUROTROL GAS-ISE METABOLITES (K121468) | Eurotrol B.V. | 2012-06-22 |
| EASYDEX (K120247) | Vineland Syrup, Inc. | 2012-06-21 |
| 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 |
| AUDIT MICROLQ SPINAL FLUID CONTROL (K112742) | Aalto Scientific, Ltd. | 2012-06-15 |
| ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SET (K121533) | Tosoh Bioscience, Inc. | 2012-06-15 |
| HOMOCYSTEINE TEST (K113793) | Roche | 2012-06-05 |
| CARESENS N MINI BLOOD GLUCOSE MONITORING SYSTEM, MINI BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIP, CONTROL SOLUTION (K120759) | I-Sens, Inc. | 2012-06-05 |
| ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT, ACE LIPASE REAGENT (K113438) | Alfa Wassermann Diagnostic Technologies, Inc. | 2012-06-01 |
| HL 568 SELF MONITORING BLOOD GLUCOSE SYSTEM, HL 568BA SELF-MONIROTING BLOOD GLUCOSE SYSTEM (K110074) | Health & Life Co., Ltd. | 2012-05-25 |
| TD-4268 BLOOD GLUCOSE MONITORING SYSTEM TD-4268 MULTI BLOOD GLUCOSE MONITORING SYSTEM (K120042) | Taidoc Technology Corporation | 2012-05-22 |
| EASYMAX MU SELF MONITORING BLOOD GLUCOSE SYSTEM, EASYMAX MU PRO SELF MONITORING BLOOD GLUCOSE SYSTEM (K121207) | Eps Bio Technology Corp. | 2012-05-18 |
| 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 |
| ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENT (K113253) | Alfa Wassermann Diagnostic Technologies, Inc. | 2012-05-17 |
| ARCHITECT B12 (K121314) | Abbott Laboratories | 2012-05-17 |
| ADVIA CHEMISTRY GLUH_3 REAGENTS (K120681) | Siemens Healthcare Diagnostics, Inc. | 2012-05-15 |
| COBAS B 123 POC SYSTEM, COBAS B 123 AUTOQC PACK TRI-LEVEL, COBAS B 123 AUTOCVC PACK, ROCHE COMBITROL PLUS B (K111188) | Roche Diagnostics | 2012-05-14 |
| ADVOCATE REDI-CODE+BMB-EA001S BLOOD GLUCOSE MONITORING SYSTEM (K120183) | Broadmaster Biotech Corperation | 2012-05-11 |
| HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE GLUCOSE (GLU) (K120369) | Hitachi Chemical Diagnostics, Inc. | 2012-05-10 |
| 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 |
| CALCIUM GEN. 2 (K113521) | Roche Diagnostics | 2012-05-08 |
| ELEMENT BLOOD GLUCOSE MONITORING SYSTEM (K113670) | Infopia Co, Ltd. | 2012-05-08 |
| PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY (K102841) | Pantex, Div. Bio-Analysis, Inc. | 2012-05-08 |
| AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON (K112790) | Axis-Shield Diagnostics, Ltd. | 2012-05-07 |
| CARESENS N POP BLOOD GLUCOSE MONITORING SYSTEM CARESENS N POP BLOOD GLUCOSE METER CARESENS N BLOOD GLUCOSE TEST STRIP CA (K120351) | I-Sens, Inc. | 2012-05-03 |
| GEM PREMIER 4000 (K112995) | Instrumentation Laboratory CO | 2012-05-03 |
| RAPIDPOINT 500 BLOOD GAS ANALYER (K113216) | Siemens Healthcare Diagnostics | 2012-05-03 |
| ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PENTRA P CONTROL; ABX PENTRA URINE CONTROL (K110530) | HORIBA ABX SAS | 2012-04-30 |
| PICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEM (K120664) | Abaxis, Inc. | 2012-04-24 |
| PICCOLO HDL-CAPILLARY TEST SYSTEM (K120662) | Abaxis, Inc. | 2012-04-24 |
| AP-3000 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION (K103230) | Bestgen Biotech Corp. | 2012-04-24 |
| HOME PREGNANCY TEST (K112315) | Newscen Coast Bio-Pharmaceutical Co., Ltd. | 2012-04-23 |
| DIAMOND TOKYO BOEKI ISE MODULE CALIBRATOR 1,2,1-2 (K120591) | Diamond Diagnostics, Inc. | 2012-04-17 |
| IND URINARY TRACT INFECTION (UTI) TEST STRIPS (K103037) | Ind Diagnostic, Inc. | 2012-04-17 |
| U-RIGHT TD-4280 BLOOD GLUCOSE MONITORING SYSTEM (K113768) | Taidoc Technology Corporation | 2012-04-12 |
| ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEMS (K112653) | ACON Laboratories, Inc. | 2012-04-09 |
| MEG-2B BLOOD GLUCOSE MONITORING SYSTEM, PRO BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE TEST STRIPS, GLUCOSE CONTROL (K120448) | Apex BioTechnology Corp. | 2012-04-06 |
| DIAZYME CYSTATIN C POC TEST KIT (K111664) | Diazyme Laboratories | 2012-03-30 |
| ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT (K112538) | Alfa Wassermann Diagnostic Technologies, Inc. | 2012-03-29 |
| RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700 (K110737) | Bionime Corporation | 2012-03-29 |
| FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM (K120568) | Abbott Diabetes Care, Inc. | 2012-03-29 |
| MULTI-CHEMISTRY STANDARD KIT, URIC ACID STANDARD KIT, URINE CHEMISTRY STARDAND KIT, URINE URIC ACID STANDARD KIT, CHOLES (K112834) | Verichem Laboratories, Inc. | 2012-03-28 |