| VARIANT II HEMOGLOBIN A1C PROGRAM (NEW), VARIANT II HEMOGLOBIN TESTING SYSTEM WITH CDM SOFTWARE, CDM SOFTWARE (K130860) | Bio-Rad Laboratories, Inc., Clinical Systems Divis | 2013-04-25 |
| HEMOSIL READIPLAS TIN (K122584) | Instrumentation Laboratory CO | 2013-03-24 |
| UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM (K120771) | Beckman Coulter, Inc. | 2013-03-22 |
| STA- COAG CONTROL (N+ABN) PLUS (K120014) | Diagnostica Stago, Inc. | 2013-03-14 |
| MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPI (K120663) | Dako North America, Inc. | 2013-02-12 |
| STA COMPACT MAX (K130090) | Diagnostica Stago, Incorporated | 2013-02-12 |
| DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET (K112120) | Diazyme Laboratories | 2013-01-24 |
| AVIE TOTAL HB TEST SYSTEM (K121752) | Mec Dynamics Corp | 2013-01-07 |
| OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 TEST KIT (K121397) | SEKISUI Diagnostics, LLC | 2012-12-28 |
| IND ONE STEP OCCULT BLOOD (FOB) TEST (K113506) | Ind Diagnostics, Inc. | 2012-12-19 |
| CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY (K110215) | Ventana Medical Systems, Inc. | 2012-12-17 |
| ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C (K121842) | Axis-Shield Diagnostics, Ltd. | 2012-12-12 |
| CAPILLARYS HEMOGLOBIN HBA1C CAPILLARYS 2 FLEX PIERCING CAPILLARYS HBA1C CONTROLS CAPILLARYS HBA1C C (K122101) | Sebia | 2012-12-06 |
| VARIANT II TURBO HBA1C KIT-2.0 VARIANT II TURBO HEMOGLOBIN TESTING SYSTEM (K122472) | Bio-Rad Laboratories, Inc., Clinical Systems Divis | 2012-10-26 |
| XN CAL PF (K120747) | Streck | 2012-10-22 |
| XN CHECK BF (K120744) | Streck | 2012-10-19 |
| SYSMEX XN-SERIES (K112605) | Sysmex America, Inc. | 2012-10-19 |
| XN CHECK (K120742) | Streck | 2012-10-19 |
| XN CAL (K120745) | Streck | 2012-10-19 |
| GLYCOSYLATED HEMOGLOBIN ASSAY; CLINICAL CHEMISTRY (K120199) | Beckman Coulter, Inc. | 2012-10-12 |
| LABONACHECK A1C (K111128) | Ceragem International, Inc. | 2012-09-13 |
| UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN ALC-(HBA1C-) REAGENT (K121492) | Beckman Coulter, Inc. | 2012-09-11 |
| HEMOCUE HBA1C 501 (K121366) | Infopia Co, Ltd. | 2012-09-07 |
| VIRTUAL SLIDE SYSTEM, OLYMPUS VS800 SYSTEM (K111914) | Olympus America Inc. / Scientific Equipment Group | 2012-08-21 |
| ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGENT, ACE T4 REAGENT, ACE FERRITIN REAGENT (K113437) | Alfa Wassermann Diagnostic Technologies, Inc. | 2012-08-06 |
| ABACUS 3CP (K111534) | Diatron U.S., Inc. | 2012-08-02 |
| VIDAS D-DIMER EXCLUSION II (DEX2) (K112818) | bioMerieux, Inc. | 2012-07-31 |
| MULTIPLATE 5.0 AGGREGOMETER (K103555) | Verum Diagnostica GmbH | 2012-07-27 |
| VIRTUSO SYSTEM FOR IHC (DO-7) (K121350) | Ventana Medical Systems, Inc. | 2012-06-01 |
| CAPILLARYS HEMOGLOBIN, CAPILLARYS FLEX PIERCING SYSTEM (K112550) | Sebia | 2012-05-25 |
| SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 2 (K112491) | Sebia | 2012-05-24 |
| EASYRA HBALC REGENT EASYCAL HBLC CALIBRATOR EASYQC HBALC MATERIAL (K120497) | Medica Corp. | 2012-05-14 |
| INRATIO2 PI/NR MONITORING SYSTEM; INRATIO PT/INR TEST STRIP (K110212) | Alere San Diego, Inc (Formally Biosite Incorporate | 2012-05-01 |
| VIRTUOSO SYSTEM FOR IHC P53 (DO-7) (K111872) | Ventana Medical Systems, Inc. | 2012-04-19 |
| HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINAL (K111999) | Healgen Scientific,, LLC | 2012-04-17 |
| ABACUS 5 (K112755) | Diatron U.S., Inc. | 2012-03-27 |
| VIRTUOSO SYSTEM FOR IHC PR (IE2) (K111869) | Ventana Medical Systems, Inc. | 2012-03-05 |
| VIRTUOSO SYSTEM FOR IHC KI-67 (30-9) (K111755) | Ventana Medical Systems, Inc. | 2012-02-22 |
| MISSION U500 URINE ANALYZER (K111221) | ACON Laboratories, Inc. | 2012-01-18 |
| HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL (K113211) | Instrumentation Laboratory CO | 2012-01-04 |
| TINA-QUANT HBA1C GEN.2 (K110313) | Roche Diagnostics | 2011-12-23 |
| CELL-DYN 22 PLUS CONTROL (K111211) | Streck | 2011-12-22 |
| CELL-DYN EMERALD 22 SYSTEM (K110381) | Abbott Laboratories | 2011-12-22 |
| CELL-DYN 22 PLUS CALIBRATOR (K111204) | Streck | 2011-12-22 |
| NOFACT IX (K102908) | R2 Diagnostics, Inc. | 2011-12-19 |
| NOFACT VIII (K102851) | R2 Diagnostics, Inc. | 2011-12-19 |
| ADVIA 2120 WITH AUTOSLIDE SYSTEM, AND ADVIA 2120I (K102644) | Siemens Healthcare Diagnostics | 2011-11-23 |
| PREMIER HB9210 HBA1C ANALYZER (K112015) | Primus Corporation Dba Trinity Biotech | 2011-11-22 |
| CONFIRM ANTI-PROGESTORONE RECEPTOR (1E2) RABBIT MONOCLONAL PRIMARY ANTIBODY (K103818) | Ventana Medical Sytems, Inc. | 2011-11-16 |
| THE BELMONT BUDDY LITE FLUID WARMER (K112639) | Belmont Instrument Corp. | 2011-11-16 |
| STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH (K111822) | Diagnostica Stago, Inc. | 2011-10-26 |
| VISUCON-F FROZEN COAG SCREEN N, VISUCON-F FROZEN COAG SCREEN ABN (K110432) | Affinity Biologicals, Inc. | 2011-10-20 |
| VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5) (K111543) | Ventana Medical Systems, Inc. | 2011-10-12 |
| CELLAVISION DM1200 WITH THE BODY FLUID APPLICTION (K102778) | CellaVision AB | 2011-09-16 |
| FOB ONE STEP RAPID TEST (K110309) | Orient Gene Biotech | 2011-09-14 |
| ADVIA CHEMISTRY HEMOGLOBIN A1C_3 (A1C_3) AUTOMATED PRETREATMENT ASSAY (K110934) | Siemens Healthcare Diagnostics | 2011-08-25 |
| HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM (K110031) | Instrumentation Laboratory CO | 2011-08-24 |
| EX-TEM. FIB-TEM, AND AP-TEM FOR ROTEM DELTA THROMBOELASTOMETRY SYSTEM (K101533) | Tem Innovations GmbH | 2011-08-10 |
| AVIE A1C TEST SYSTEM (K093548) | Mec Dynamics Corp | 2011-07-20 |
| HEMOSIL FACTOR VIII DEFICIENT PLASMA (K110237) | Instrumentation Laboratory CO | 2011-07-08 |
| AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5 (K100716) | Aalto Scientific, Ltd. | 2011-06-23 |
| HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS) (K111339) | Medtronic, Inc. | 2011-06-08 |
| INVADER FACTOR II (K100943) | Hologic, Inc. | 2011-06-02 |
| INVADER FACTOR V (K100980) | Hologic, Inc. | 2011-06-01 |
| CELL-CHEX WITH CPPD CRYSTALS (K110718) | Streck | 2011-05-26 |
| ELITECH CLINICAL SYSTEMS HBA1C REAGENT, ELITECH CLINCAL SYSTEM HBA1C CALIBRATOR SET, ELITECH CLINICAL (K100547) | Seppim S.A.S. | 2011-05-19 |
| DIAZYME GLYCATED SERUM PROTEIN ASSAY / CALIBRATOR KIT / CONTROL KIT (K110188) | Diazyme Laboratories | 2011-05-17 |
| STRATUS CS ACUTE CARE D-DIMER (K110303) | Siemens Healthcare Diagnostics | 2011-05-16 |
| INVADER MTHFR 677 (K100987) | Hologic, Inc. | 2011-05-13 |
| DIMENSIONS HB1C KIT, MODEL DF105A (K102510) | Siemens Healthcare Diagnostics | 2011-05-13 |
| R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL (K101578) | R&D Systems, Inc. | 2011-04-28 |
| INVADER MTHFR 1298 (K100496) | Hologic, Inc. | 2011-04-25 |
| HEMOSIL LA POSITIVE CONTROL (K102552) | Instrumentation Laboratory CO | 2011-04-05 |
| HEMOSIL PROTEIN S ACTIVITY ASSAY (K102164) | Instrumentation Laboratory CO | 2011-03-17 |
| BD FACS SAMPLE PREP ASSISTANT III (SPA III) (K102064) | Becton, Dickinson & CO | 2011-03-07 |
| EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM; EKF-DIAGNOSTIC HEMOGLOBIN MICROCUVETTES (MODIFIED CURVETTE W (K110393) | Ekf-Diagnostic GmbH | 2011-03-04 |
| AFINION ANALYZER (K110056) | Axis-Shield Poc AS | 2011-02-15 |
| DIMENSION VISA HBA1C, MODEL K3105A (K102045) | Siemens Heatlhcare Diagnostics, Inc. | 2011-02-14 |
| HEMA SCREEN ER (K102664) | Immunostics Inc., | 2011-01-28 |
| TQ HBA1C GEN3 (K102914) | Roche | 2011-01-20 |
| LUPOTEK KCT (K090105) | R2 Diagnostics, Inc. | 2010-12-30 |
| COULTER LIN-X LINEARITY CONTROL, MODEL A81196 (K100790) | Beckman Coulter, Inc. | 2010-12-21 |
| PT-MULTI-CALIBRATOR, MODEL OPAT07 (K093848) | Dade Behring, Inc. | 2010-12-20 |
| SPECIALTY ASSAYED CONTROL-2 (K100103) | Helena Laboratories | 2010-12-15 |
| CLOTRAC HEPARINASE TEST CARTIDGE (HTC) COAGULATION CONTROL (K103314) | Medtronic, Inc. | 2010-12-03 |
| HEPARIN ASSAY CONTROLS (K103313) | Medtronic, Inc. | 2010-12-01 |
| INNOVANCE D-DIMER, MODEL OPBP09 (K093626) | Siemens Healthcare Diagnostics | 2010-11-29 |
| COULTER 4C-EX 300 CELL CONTROL (K100607) | Beckman Coulter, Inc. | 2010-11-18 |
| HEPARIN DOSE RESPONSE CARTRIDGE (K102953) | Medtronic, Inc. | 2010-11-04 |
| PATHIAM SYSTEM WITH ISCAN FOR P53 AND KI-67 (K092333) | Bioimagene, Inc. | 2010-10-27 |
| DXH 300 COULTER CELLULAR ANALYSIS SYSTEM, DXH 300C COULTER CELLULAR ANALYSSI SYSTEM MODEL: 71772, 71771 (K100489) | Beckman Coulter Cellular | 2010-10-26 |
| IMMUKNOW-THE CYLEX IMMUNE CELLFUNCTION ASSAY (K101911) | Cylex, Inc. | 2010-10-18 |
| HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XX (K101271) | Medtronic, Inc. | 2010-10-13 |
| ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800 (K101831) | Bionostics, Inc. | 2010-10-01 |
| IQ 200 URINE ANALIZER BODY FLUIDS MODULE (K091539) | Iris Diagnostics | 2010-08-31 |
| ST AIA PACK HBA1C (K100304) | Tosoh Bioscience, Inc. | 2010-08-27 |
| CELLTRACKS AUTOPREP SYSTEM MODEL:9541 (K100684) | Veridex, LLC | 2010-08-26 |
| CELL-CHEX (K101335) | Streck | 2010-08-23 |
| LIQUICHEK HEMATOLOGY-16 CONTROL LV, MODEL: 295LV (K091303) | Bio-Rad Laboratories | 2010-08-02 |
| ADVIA 2120/2120I BODY FLUIDS (K090346) | Siemens Healthcare Diagnostics | 2010-07-28 |