| SMARTLOG DIABETES MANAGEMENT SOFTWARE (K133346) | I-Sens, Inc. | 2013-12-19 |
| LP(A) CALIBRATORS, AND LP(A) CONTROLS (K132400) | Biokit, S.A. | 2013-12-19 |
| COBAS C 501 ISE INDIRECT NA, K, CL FOR GEN. 2 (K132418) | Roche Diagnostics | 2013-12-18 |
| HEALTHPRO PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM (K132862) | Infopia Co, Ltd. | 2013-12-12 |
| GLUNEO LITE GLUCOSE MONITORING SYSTEM, GLUNEO LITE PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM (K132966) | Infopia Co, Ltd. | 2013-12-05 |
| ELECSYS CALCITONIN; IMMUNOASSAY, CALSET, CALCHECK 5; ELECSYS PRECICONTROL VARIA 3 (K132828) | Roche Diagnostics | 2013-12-04 |
| PRODIGY CHOICE (K122340) | Prodigy Diabetes Care, LLC | 2013-11-26 |
| C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEIN (K133330) | Roche Diagnostics | 2013-11-26 |
| ELECSYS CK-MB CALCHECK 5 (K133284) | Roche Diagnostics | 2013-11-22 |
| GLB BENECHECK PREMIUM GLU MONITORING SYSTEM (K123090) | General Life Biotechnology Co., Ltd. | 2013-11-22 |
| ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT (K133067) | Siemens Healthcare Diagnostics, Inc. | 2013-11-22 |
| CARESENS N VOICE MULTI BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N VOICE MULTI BLOOD GLUCOSE METER (K132288) | I-Sens, Inc. | 2013-11-22 |
| INFLAMMA DRY (K132066) | Rapid Pathogen Screening, Inc. | 2013-11-21 |
| RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR (K123977) | Randox Laboratories, Ltd. | 2013-11-21 |
| AGAMATRIX HEALTH MANAGER (K132821) | Agamatrix, Inc. | 2013-11-20 |
| MISEQDX UNIVERSAL KIT 1.0 (DEN130042) | Illumina, Inc. | 2013-11-19 |
| GSP NEONATAL BIOTINIDASE KIT (K131284) | Wallac OY | 2013-11-14 |
| ONE STEP HCG TEST STRIP, ONE STEP HCG TEST CASSETTE, ONE STEP HCG TEST MIDSTREAM (K132085) | Co-Innovation Biotech Co., Ltd. | 2013-11-12 |
| LIAISON N-TACT PTH GEN II, CONTROL SET, CALIBRATION VERIFIERS (K132515) | DiaSorin, Inc. | 2013-11-08 |
| UCP PREGNANCY CASSETTE TEST, DIP/CARD STRIP, HOME PREGNANCY CASSETTE TEST, MIDSTREAM TEST AND DIP/CARD STRIP (K131236) | Ucp Biosciences, Inc. | 2013-11-07 |
| UNISTRIP 1 (K113135) | Unistrip Technologies, LLC | 2013-11-06 |
| PREFERRED BLOOD GLUCOSE MONITORING SYSTEM (K122338) | Prodigy Diabetes Care, LLC | 2013-11-05 |
| IMMULITE 2000; 3GALLERGY SPECIFIC IGE CONTROL VERIFICATION MATERIAL (CVM), TOTAL IGE CONTROL VERIFICATION MATERIAL (CVM) (K133122) | Siemens Healthcare Diagnostics, Inc. | 2013-10-30 |
| S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE (K132462) | Hitachi Chemical Diagnostics, Inc. | 2013-10-28 |
| LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-LEVEL I, LIQUICHEK IMMUNOASSAY (K132227) | Bio-Rad Laboratories | 2013-10-25 |
| IMMULITE 2000; TOTAL T3 CALIBRATION VERIFICATION MATERIAL, TOTAL T4 CALIBRATION VERIFICATION MATERIAL, TOTAL TBG CALIBRA (K133124) | Siemens Healthcare Diagnostics, Inc. | 2013-10-25 |
| DA01 BLOOD GLUCOSE MONITORING SYSTEM (K132338) | Delbio Incorporation | 2013-10-24 |
| RIGHTEST CONTROL SOLUTION (K133003) | Bionime Corporation | 2013-10-24 |
| RANDOX CSF CONTROLS LEVELS 2 AND 3 (K132156) | Randox Laboratories, Ltd. | 2013-10-23 |
| IMMULITE 2000; HCG CALIBRATION VERIFICATION MATERIAL, INSULIN CALIBRATION VERIFICATION MATERIAL, PYRILINKS-D CALIBRATION (K133128) | Siemens Healthcare Diagnostics, Inc. | 2013-10-22 |
| MULTICHEM S PLUS / S PLUS (ASSAYED) (K132751) | Techno-Path Manufacturing , Ltd. | 2013-10-22 |
| ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY (K132571) | Roche Diagnostics | 2013-10-18 |
| GLOOKO DEVICE SYSTEM FOR GLOOKO APPLICATION (K132272) | Glooko, Inc. | 2013-10-17 |
| FOCUS BLOOD GLUCOSE MONITORING SYSTEM, FOCUS PRO BLOOD GLUCOSE MONITORING SYSTEM (K131013) | Nova Biomedical Corporation | 2013-10-17 |
| ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP CALIBRATOR (K132664) | Siemens Healthcare Diagnostics, Inc. | 2013-10-16 |
| MULTICHEM U (K131993) | Techno-Path Manufacturing , Ltd. | 2013-10-15 |
| ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM (K131366) | Roche Diagnostics Operations, Inc. | 2013-10-11 |
| IMMULITE 2000 ACTH CALIBRATION VERIFICATION MATERIAL (K131662) | Siemens Healthcare Diagnostics, Inc. | 2013-10-10 |
| AU BICARBONATE REAGENT (K131546) | Beckman Coulter Ireland, Inc. | 2013-10-09 |
| V8 SP NORMAL CONTROL, ABNORMAL CONTROL (K131479) | Helena Laboratories | 2013-10-07 |
| PATHFAST CK-MB-II CALIBRATORS (K130628) | Mitsubishi Chemical Medience Corporation | 2013-10-04 |
| ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENT (K131975) | Alfa Wassermann Diagnostic Technologies, Inc. | 2013-10-02 |
| ACCESS TOTAL BHCG (5TH IS) (K130020) | Beckman Coulter, Inc. | 2013-10-01 |
| CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITOR (K122370) | Bayer Healthcare | 2013-09-26 |
| MULTICHEM P (K131992) | Techno-Path Manufacturing , Ltd. | 2013-09-25 |
| ACCESS ACCUTNI REAGENT, ACCESS ACCUTNI CALIBRATOR, UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM (K121790) | Beckman Coulter, Inc. | 2013-09-25 |
| MULTICHEM IA AND IA PLUS (K132091) | Techno-Path Manufacturing , Ltd. | 2013-09-20 |
| IMMULITE 2000 ANTI-TG AB CALIBRATION VERIFICATION MATERIAL, IMMULITE 2000 ANTI-TPO AB CALIBRATION VERIFICATIN MATERIAL (K132391) | Siemens Helathcare Diagnostics, Inc. | 2013-09-20 |
| ABL90 FLEX ANALYZER (K131988) | Radiometer Medical Aps | 2013-09-17 |
| ADVIA CENTAUR FT4, ADVIA CENTAUR T4 (K132249) | Siemens Healthcare Diagnostics, Inc. | 2013-09-13 |
| FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST (K123567) | Church & Dwight Co., Inc. | 2013-09-10 |
| LIAISON XL HCG (K131037) | DiaSorin, Inc. | 2013-09-06 |
| LIAISON 25 TOTAL-D (K132492) | DiaSorin, Inc. | 2013-09-05 |
| ONETOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM (K131363) | Cilag GmbH International | 2013-08-30 |
| IMPROVE BLOOD COLLECTION SET AND IMPROSAFE BLOOD COLLECTION SET (K123987) | Innovative Medical Technologies, Inc. | 2013-08-27 |
| FIRST RESPONSE EARLY RESULT PREGNANCY TEST (K123436) | Church & Dwight Co., Inc. | 2013-08-26 |
| DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM (K130244) | Delbio Incorporation | 2013-08-23 |
| VANISHPOINT BLOOD COLLECTION SET (K122355) | Retractable Technologies, Inc. | 2013-08-23 |
| OPTI CCA-TS2 (K131126) | Opti Medical Systems, Inc. | 2013-08-22 |
| CARESENS N LINK BLOOD GLUCOSE MONITORING SYSTEM; CARESENS N LINK MULTI BLOOD BLUCOSE MONITORING SYSTEM (K130696) | I-Sens, Inc. | 2013-08-21 |
| ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENT (K131488) | Alfa Wassermann Diagnostics Technologies, LLC | 2013-08-19 |
| ACE ALKALINE PHOSPHATASE REAGENT, AMYLASE REAGENT, ALT REAGENT, AST REAGENT (K131351) | Alfa Wassermann Diagnostic Technologies, LLC | 2013-08-15 |
| TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRI PRO PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM (K132072) | Nipro Diagnostics, Inc. | 2013-08-15 |
| EBCHEK BLOOD GLUCOSE MONITORING SYSTEM (K122181) | Visgeneer, Inc. | 2013-08-15 |
| ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENT (K131515) | Alfa Wassermann | 2013-08-14 |
| IMMULITE 2000 PSA CALIBRATION VERIFICATION MATERIAL (K131536) | Siemens Healthcare Diagnostics, Inc. | 2013-08-12 |
| HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY (K130685) | Hitachi Chemical Diagnostics, Inc. | 2013-08-09 |
| ACURA PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM (K131419) | I-Sens, Inc. | 2013-08-09 |
| ACCU-CHEK AVIVA PLUS TEST STRIP (K131029) | Roche Diagnostics Operations, Inc. | 2013-08-09 |
| COBAS C 501 TINA-QUANT HBA1CDX GEN.3 ASSAY (K121610) | Roche Diagnostics Operations | 2013-08-08 |
| SOFIA(R) HCG FIA (K131166) | Quidel Corp. | 2013-08-02 |
| BD FACS SAMPLE PREP ASSISTANT III (K131301) | Becton, Dickinson & CO | 2013-08-02 |
| ABL90 FLEX (K130144) | Radiometer Medical Aps | 2013-07-31 |
| GLUNEO BLOOD GLUCOSE MONITORING SYSTEM, AND PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM (K130181) | Infopia Co, Ltd. | 2013-07-31 |
| BROADMASTER HEALTHCARE SYSTEM (K130621) | Broadmaster Biotech Corporation | 2013-07-30 |
| HBA1C CONTROL, LEVEL 1 AND LEVEL 2 (K131999) | Randox Laboratories, Ltd. | 2013-07-26 |
| CHEMTRUE(R) HCG PREGNANCY URINE MIDSTREAM TEST (K131931) | Chemtron Biotech, Inc. | 2013-07-26 |
| CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2 FLEX PIERCING INSTRUMENT (K130500) | Sebia | 2013-07-26 |
| EUROTROL GAS-ISE HCT QC AND EUROTROL GAS-ISE HCT LVM (K131595) | Eurotrol B.V. | 2013-07-26 |
| ALDOLASE CONTROLS LEVEL 2, AND ALDOLASE CONTROL LEVEL 3 (K131776) | Randox Laboratories, Ltd. | 2013-07-18 |
| 25-OH VITAMIN D ELISA (K123660) | Euroimmun US | 2013-07-17 |
| COBAS C BILIRUBIN TOTAL GEN.3 (K131544) | Roche Diagnostics | 2013-07-17 |
| LINKDR 2.0 DIABETES MANAGEMENT SOFTWARE (K130657) | All Medicus Co., Ltd. | 2013-07-15 |
| 25OH VITAMIN D TOTAL ELISA TEST (K123364) | Diasource Immunoassays, S.A. | 2013-07-15 |
| TQ-PREP WORKSTATION, PREPPLUS 2 WORKSTATION (K130253) | Beckman Coulter, Inc. | 2013-07-15 |
| THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS (K123343) | Microgenics Corp. | 2013-07-11 |
| FASTPACK VITAMIN D; IMMUNOASSAY, CALIBRATORS, CONTROLS, VERIFIERS (K123983) | Qualigen, Inc. | 2013-07-03 |
| ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AND ABX PENTRA P CONT (K123171) | HORIBA ABX SAS | 2013-07-03 |
| SOLUSMOBILE BLOOD GLUCOSE MANAGMENT SYSTEM (K123559) | Biotest Medical Corp. | 2013-06-28 |
| FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM (K130094) | Abbott Diabetes Care | 2013-06-27 |
| DIAZYME LIPOPROTEIN (A) CALIBRATOR SET, CONTROL SET (K131556) | Diazyme Laboratories | 2013-06-26 |
| LIPIDPRO LIPID PROFILE AND GLUCOSE MEASURING SYSTEM, LIPIDPRO PROFESSIONAL LIPID PROFILE AND GLUCOSE MEASURING SYSTEM. (K130295) | Infopia Co, Ltd. | 2013-06-21 |
| SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KIT (K121101) | Astoria-Pacific, Inc. | 2013-06-20 |
| RANDOX SPECIALITY CONTROL (I) LEVELS 1, 2 AND 3 (K130337) | Randox Laboratories Limited | 2013-06-19 |
| VERI-Q MGD-1001 BLOOD GLUCOSE MONITORING SYSTEM, VERI-Q PLUS MGD-1001 BLOOD GLUCOSE MONITORING SYSTEM (K123007) | Mico Biomed Co., Ltd. | 2013-06-19 |
| VERI-Q SELF-TESTING AND VERI-Q PLUS MGD-2001 BLOOD GLUCOSE MONITORING SYSTEMS (K123016) | Mico Biomed Co., Ltd. | 2013-06-18 |
| IDS ISYS 1,25 DIHYDROXY VITAMIN D, IDS-ISYS, 1,25 DIHYDROXY VITAMIN D CONTROL SET, AND IDS ISYS 1,25 DIHYDROXY VITAMIN D (K123253) | Immunodiagnostic Systems , Ltd. | 2013-06-18 |
| TYSONBIO AC500, AC800 BLOOD GLUCOSE MONITORING SYSTEM, TYSONBIO AC500 AC800 PRO BLOOD GLUCOSE MONITORING SYSTEM (K123087) | Tyson Bioresearch, Inc. | 2013-06-18 |
| ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE ACCESS 2 IMMUNOASSAY SYSTEM (K121214) | Beckman Coulter, Inc. | 2013-06-14 |
| VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406 (K123127) | Maine Standards Co. | 2013-06-14 |