| EM44 SELF MONITORING BLOOD GLUCOSE SYSTEM, EM44 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM (K112272) | Eps Bio Technology Corp. | 2011-09-07 |
| 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 |
| FORA GD20 BLOOD GLUCOSE MONITORING SYSTEM, U-RUGHT TD-4252D BLOOD GLUCOSE MONITORING SYSTEM (K101631) | Taidoc Technology Corporation | 2011-09-02 |
| POLY-CHEM 90 TOTAL BILIRUBIN (K111143) | Polymedco, Inc. | 2011-09-01 |
| MEG-2 BLOOD GLUCOSE MONITORING SYSTEM, MEG-2 50'S TEST STRIP, MEG-2 CONTROL SOLUTION (K101204) | Apex BioTechnology Corp. | 2011-08-31 |
| TD-4239 BLOOD GLUCOSE MONITORING SYSTEM AND TD-4239 MULTI BLOOD GLUCOSE MONITORING SYSTEM (K101635) | Taidoc Technology Corporation | 2011-08-31 |
| ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYS (K103747) | Elitechgroup Seppim S.A.S. | 2011-08-31 |
| TYSONBIO BLOOD GLUCOSE MONITORING SYSTEM, MODELS AC100 AND AC200 (K101543) | Tyson Bioresearch, Inc. | 2011-08-30 |
| ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II MODEL CALI-05 (K112029) | Elitechgroup | 2011-08-30 |
| NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM (K110648) | Nova Biomedical Corporation | 2011-08-29 |
| ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE, AG-608 SINGLE & AG-608 MULTI BLOOD GLUCOSE MONITORING SYSTEMS (K102678) | Andon Medical Co., Ltd. | 2011-08-26 |
| ELECSYS N-MID OSTEOCALCIN CALCHECK 5 (K112104) | Roche Diagnostics | 2011-08-25 |
| ACCESS FOLATE CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS MODEL A98033 (K111952) | Beckman Coulter, Inc. | 2011-08-19 |
| CKMB UDR ASSAY (K102706) | SENTINEL CH. SpA | 2011-08-19 |
| NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPS (K100602) | Nova Biomedical Corp. | 2011-08-17 |
| RAPIDPOINT 405 NEONATAL BILIRUBIN (K110277) | Siemens Healthcare Diagnostics | 2011-08-15 |
| ABX PENTRA ENZYMATIC CREATININE CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P CONTROL, AND ABX PENTRA URIN (K110137) | HORIBA ABX SAS | 2011-08-10 |
| BLOOD GLUCOSE MONITORING SYSTEM, MODELS AG-6081 AND AG-6951 (K101307) | Andon Medical Co., Ltd. | 2011-08-09 |
| CYBOW READER, MODELS 300 & 720 (K102188) | DFI Co., Ltd. | 2011-08-09 |
| ST AIA-PACK DHEA-S CALIBRATOR SET (K111762) | Tosoh Bioscience, Inc. | 2011-08-05 |
| ATLAS HOME PREGNANCY TEST (MIDSTREAM FORMAT) MODEL 70172001 (K102760) | Atlas Medical | 2011-08-03 |
| TELCARE BLOOD GLUCOSE MONITORING SYSTEM, TEST STRIPS, CONTROL SOLUTIONS, TELSERVE-HOME USE, TELSERVE-PROFESSIONAL USE (K110571) | Telcare, Inc. | 2011-07-28 |
| PREGNANCY ONE STEP RAPID TEST (K103574) | Lehnus & Associates Consulting | 2011-07-28 |
| ELECSYS T3 CALCHECK 5 (K111552) | Roche Diagnostics | 2011-07-21 |
| ABL90 (K111897) | Radiometer Medical Aps | 2011-07-19 |
| SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT (K102643) | Astoria-Pacific, Inc. | 2011-07-15 |
| AG-695 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM/AG-696 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM (K093755) | Andon Medical Co., Ltd. | 2011-07-15 |
| EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; EASYRA TRIG REAGENT (K111036) | Medica Corporation | 2011-07-12 |
| ELECSYS PRECICONTROL VARIA 3 (K111506) | Roche Diagnostics | 2011-07-08 |
| FORA POCT S10/TD-4258 BLOOD GLUCOSE MONITORING SYSTEM (K092688) | Taidoc Technology Corporation | 2011-07-06 |
| VALIDATE (R) GC3 CALIBRATION VERIFICATION / LINEARITY TEST KIT (K110880) | Maine Standards Company, LLC | 2011-07-05 |
| FORA POCT MANAGMENT SYSTEM (K111029) | Taidoc Technology Corporation | 2011-07-01 |
| 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 |
| INDIKO (K110035) | Thermofisher Scientific OY | 2011-06-28 |
| U-RIGHT TD-4279 BLOOD GLUCOSE MONITORING SYSTEM, FORA GD40/TD-4272 BLOOD GLUCOSE MONITORING SYSTEM (K101509) | Taidoc Technology Corporation | 2011-06-27 |
| EASYMAX T1 SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL EPS10042 (K102345) | Eps Bio Technology Corp. | 2011-06-21 |
| ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO; ELITECH CLINICAL SYSTEMS ALBUMIN; ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH (K110830) | Elitechgroup | 2011-06-21 |
| IND ONE STEP HCG URINE PREGNANCY TEST (STRIP) (K110889) | Ind Diagnostics, Inc. | 2011-06-20 |
| ABBOTT ARCHITECT LH CALIBRATORS (K111023) | Abbott Laboratories | 2011-06-10 |
| AUTODELFIA NEONATAL IRT KIT (K110274) | Wallac Oy, A Subsidiary of Perkinelmer, Inc. | 2011-06-10 |
| AUDIT MICROCV IMMUNOASSAY LINEARITY SET (K103601) | Aalto Scientific, Ltd. | 2011-06-10 |
| ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON) (K110394) | Vital Diagnostics (Manufacturing) Ptyltd | 2011-06-09 |
| ELECSYS SHBG CALCHECK 5 (K111349) | Roche Diagnostics | 2011-06-09 |
| ADVIA CENTAUR CALIBARATOR 80 MODEL 10492491 (K103548) | Siemens Healthcare Diagnostics, Inc. | 2011-06-02 |
| CLEVER CHOICE VOICE+ BLOOD GLUCOSE MONITORING SYSTEM (K102049) | Taidoc Technology Corporation | 2011-05-27 |
| FUJIREBIO DIAGNOSTICS VITAMIN D CONTROL (K110641) | Fujirebio Diagnostics,Inc. | 2011-05-27 |
| SYNCHRON MULTI CALIBRATOR (K110251) | Beckman Coulter, Inc. | 2011-05-25 |
| EG V1 (BL) SELF MONITORING GLUCOSE TEST SYSTEM MODEL: EPS10017 (K101037) | Eps Bio Technology Corp. | 2011-05-23 |
| EASYRA ALKALINE PHOSPHATASE, ASPARTATE AMINOTRANSFERASE AND AMYLASE REAGENTS (K101090) | Medica Corp. | 2011-05-20 |
| ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SL (K102993) | Seppim S.A.S. | 2011-05-19 |
| ARK CARE DIABETES MANAGMENT SYSTEM (K110709) | Arkray Factory USA, Inc. | 2011-05-19 |
| PATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST SAMPLE DILUENT 2 (K100130) | Mitsubishi Chemical Medience CO | 2011-05-16 |
| HEALTH CARE SYSTEM SOFTWARE (K110948) | Taidoc Technology Corporation | 2011-05-13 |
| DROPPER A1C DIABETES CONTROL (K103744) | Quantimetrix Corp. | 2011-05-12 |
| ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSET (K103716) | Roche Diagnostics | 2011-05-12 |
| ELECSYS PROLACTIN II CALCHECK 5 (K110613) | Roche Diagnostics | 2011-05-12 |
| CLEARBLUE EASY PREGNANCY TEST (K110433) | SPD Development Company Limited | 2011-05-12 |
| POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTIONS (K110413) | Beckman Coulter, Inc. | 2011-05-11 |
| ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTS (K100263) | Seppim S.A.S. | 2011-05-06 |
| MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, LEVEL 2, DUAL LEVEL (K103364) | Diamond Diagnostics, Inc. | 2011-05-06 |
| URIC ACID MODEL 3P39 (K102568) | Abbott Laboratories | 2011-05-06 |
| AFFYMETRIX GENE PROFILING REAGENTS (K103112) | Affymetrix, Inc. | 2011-05-04 |
| IMMULITE/IMMULITE 1000 PROGESTERONE CALIBRATION VERIFICATION (CVM) (K103683) | Siemens Healthcare Diagnostics | 2011-04-28 |
| AUTOSURE VOICE 3 BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIP (K102481) | Apex BioTechnology Corp. | 2011-04-28 |
| UNICEL DXC 600 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 AND UNICEL DXC 800 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 (K103842) | Beckman Coulter, Inc. | 2011-04-27 |
| GSP NEONATAL THYROXINE (T4) (K103484) | Wallac Oy, A Subsidiary of Perkinelmer, Inc. | 2011-04-22 |
| EASYRA UREA NITROGEN AND CREATININE REAGENTS (K110675) | Medica Corp. | 2011-04-21 |
| FDI GLUCOSE CONTROL SOLUTION FOR AVIVA (K110436) | Fujirebio Diagnostics,Inc. | 2011-04-20 |
| DIMENSION VISTA CDT CAL, DIMENSION VISTA CDT CON L, DIMENSION VISTA CDT CON H (K110169) | Siemens Healthcare Diagnostics | 2011-04-07 |
| EASYRA ALBUMIN, CALCIUM, MAGNESIUM AND INORGANIC PHOSPHOROUS REAGENT (K101088) | Medica Corp. | 2011-04-04 |
| ELITECH CLINICAL SYSTEMS SELECTRA PROM/ELICAL 2/ELITROL I AND ELITROL II/AST/GOT 4+1 SL/POTASSIUM, SODIUM, CHLORIDE... (K102647) | Elitechgroup Vital Scientific BV | 2011-03-24 |
| ABL835 FLEX ANALYZER WITH PLEURAL PH (K110416) | Radiometer Medical Aps | 2011-03-24 |
| CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT (K101852) | Iris International Inc., A Division of Iris Iris I | 2011-03-23 |
| IVD-GE02 (K101947) | Sphere Medical , Ltd. | 2011-03-16 |
| IDS-ISYS IFG-I CONTROL SET (K110412) | Immunodiagnostic Systems , Ltd. | 2011-03-16 |
| ADVIA CHEMISTRY GLUCOSE HEXOKINASE_3 (GLUH_3) REAGENT, MODELS REF 05001429 (K101854) | Siemens Healthcare Diagnostics | 2011-03-07 |
| ADVIA CHEMISTRY LIQUID SPECIFIC PROTEIN CALIBRATORS (K103701) | Siemens Healthcare Diagnostics, Inc. | 2011-02-18 |
| FASTPACK TESTO IMMUNOASSAY (K101388) | Qualigen, Inc. | 2011-02-18 |
| TECO DIAGNOSTICS UTI DETECTION STRIPS (K100024) | Teco Diagnostics | 2011-02-17 |
| ENZYME II CALIBRATOR (K103836) | Siemens Healthcare Diagnostics, Inc. | 2011-02-16 |
| ELECSYS ANTI-TPO CALSET (K103171) | Roche Diagnostics | 2011-02-11 |
| ONE TOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM (K093745) | Lifescan, Inc. | 2011-02-11 |
| LIFESCAN ONETOUCH SELECT / ULTRA / VITA GLUCOSE CONTROL SOLUTION (K103553) | Bionostics, Inc. | 2011-02-10 |
| I-STAT 1 WIRELESS ANALYZER (K103195) | Abbott Point of Care, Inc. | 2011-02-08 |
| URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10 (K101673) | Teco Diagnostics | 2011-02-04 |
| MULTICONSTITUENT CALIBRATOR (K103403) | Abbott Laboratories | 2011-02-04 |
| NEOPAC SOFTWARE, 3007 DIGITAL PHOTOMETER/FLUOROMETER MODEL NA, 307 AND 350D (K101392) | Astoria-Pacific, Inc. | 2011-02-04 |
| MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY STRIP URINE CONTROL (K103387) | ACON Laboratories, Inc. | 2011-02-02 |
| DIATRON PICTUS 400 (K101741) | Diatron Group | 2011-01-25 |
| MSC LIPID CONTROL (K103271) | Maine Standards Co. | 2011-01-25 |
| FDI GLUCOSE CONTROL SOLUTION FOR FREESTYLE (K103450) | Fujirebio Diagnostics,Inc. | 2011-01-25 |
| DIMENSION VISA ENZ 2 CAL (K103612) | Siemens Healthcare Diagnostics, Inc. | 2011-01-25 |
| ELECYSYS SHBG (K102814) | Roche Diagnostics | 2011-01-20 |
| AUDIT MICROCV PROTEIN LINEARITY SET (K101216) | Aalto Scientific, Ltd. | 2011-01-14 |
| PROLYTE ELECTROLYTE ANALYZER (K102959) | Diamond Diagnostics, Inc. | 2011-01-14 |
| EASYRA SODIUM ASSAY, EASYRA POTASSIUM ASSAY, EASYRA CHLORIDE ASSAY, EASYRA CARBON DIOXIDE ASSAY MODEL CAT NO. 5423 & 520 (K100829) | Medica Corp. | 2011-01-14 |
| DIAZYME 25-HYDROXY VITAMIN D ASSAY KIT MODEL DZ688A, DIAZYME 25-HYDROXY VITAMIN D ASSAY CALIBRATOR SET MODEL DZ688A-CAL, (K102432) | Diazyme Laboratories | 2011-01-14 |
| AUDIT MICROCV CARDIAC MARKERS LINEARITY SET (K102617) | Aalto Scientific, Ltd. | 2011-01-10 |
| ELECSYS DHEA-S CALCHECK 5 (K103402) | Roche Diagnostics | 2011-01-07 |