meddevicedb.com FDA Device Reference

Review Panel

Hematology FDA 510(k) Clearances & Devices

Cleared Devices
4,197
Product Codes (page)
41
Latest Decision
2006-05-10

Clearances · page 7 of 42

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K060656 SYSMEX AUTOMATED HEMATOLOGY ANALYZER MODELS XS SERIES Sysmex America, Inc. GKZ Class II 2006-05-10
K060930 INSURE II Enterix, Inc. KHE Class II 2006-05-04
K053111 STA-CEPHASCREEN KIT Diagnostica Stago, Inc. GFO Class II 2006-05-04
K060931 HEMOSIL PT-FIBRINOGEN HS PLUS Instrumentation Laboratory CO GJS Class II 2006-05-02
K060462 NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN PROGESTERONE RECEPTOR ANTIBODY (CLONE SP2) Lab Vision Corp. MXZ Class II 2006-04-24
K053497 GUAVA EZCD4 SYSTEM Guava Technologies, Inc. GKZ Class II 2006-04-14
K060688 HEMOSIL SYNTHASIL Instrumentation Laboratory CO GFO Class II 2006-04-13
K053520 VENTANA IMAGE ANALYSIS SYSTEM, MODEL KI-67 Tripath Imaging, Inc. NQN Class II 2006-04-11
K060650 VITROS CHEMISTRY PRODUCTS D%A1C REAGENT KIT, MODEL 680 2314; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 18, MODEL 680 1702 Ortho-Clinical Diagnostics, Inc. LCP Class II 2006-04-06
K060464 COULTER 5C CELL CONTROL Beckman Coulter, Inc. JPK Class II 2006-03-28
K052598 IMMOCARE Care Diagnostic, Inc. KHE Class II 2006-03-16
K050709 RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, FR-9367 Wallac OY GKA Class II 2006-03-08
K060162 ACL ELITE; ACL ELITE PRO Instrumentation Laboratory CO JPA Class II 2006-02-21
K060083 NRBC-CHEX FOR LH Streck GJR Class II 2006-02-09
K053411 DRI HEMOGLOBIN A1C ASSAY AND CALIBRATORS Microgenics Corp. LCP Class II 2006-02-03
K052577 IKONISCOPE FASTFISH AMNIO IMAGING SYSTEM Ikonisys, Inc. JOY Class II 2006-01-24
K060001 D-10 HEMOGLOBIN A1C PROGRAM; D-10 DUAL PROGRAM Bio-Rad Laboratories, Inc. LCP Class II 2006-01-20
K052825 VISULIZE FACTOR VIII ANTIGEN KIT, MODEL FVIII-AG Affinity Biologicals, Inc. GGP Class II 2006-01-20
K053559 PF4 ENHANCED SOLID PHASE ELISA Genetic Testing Institute LCO Class II 2006-01-20
K053499 HEMOSIL PROS Instrumentation Laboratory CO GGP Class II 2006-01-13
K053362 CELL-CHEX AUTO Streck JPK Class II 2006-01-13
K052697 HEPARIN/PLATELET FACTOR 4 ANTIBODY SERUM PANEL Akers Biosciences, Inc. GGN Class II 2006-01-04
K053135 SYSMEX UF-100I AUTOMATED URINE CELL ANALYZER Sysmex America, Inc. LKM Class II 2006-01-04
K053308 ABX MICROS CRP 200, OPTION IM Horiba Abx GKZ Class II 2005-12-29
K050365 BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202 Hyphen Biomed GGP Class II 2005-12-27
K051472 BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH CALIBRATOR Hyphen Biomed GGN Class II 2005-12-23
K051030 COAG-A-MATE MTX III bioMerieux, Inc. JPA Class II 2005-12-23
K050758 CHEMPAQ XBC ANALYZER Chempaq A/S GKZ Class II 2005-12-22
K050817 T-TEK R2 Diagnostics, Inc. GJA Class II 2005-12-12
K051693 MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM Bayer Healthcare, LLC GKL Class II 2005-12-07
K053031 EXTENDSURE HBFASC CONTROL Cantebury Scientific , Ltd. JCM Class II 2005-12-07
K052905 MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER Beckman Coulter, Inc. GKZ Class II 2005-11-18
K052838 LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4 Bio-Rad GGM Class II 2005-11-09
K043007 BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105 Hyphen Biomed JBQ Class II 2005-11-07
K052124 ACTICLOT, MODEL 824 American Diagnostica, Inc. GJS Class II 2005-10-17
K050265 CHRONO-LOG WHOLE BLOOD LUMI-AGGREGOMETER, MODEL 700 Chrono-Log Corp. JOZ Class II 2005-10-14
K052547 BELMONT BUDDY FLUID WARMER Belmont Instrument Corp. BSB Class II 2005-10-13
K051806 CARE FECAL OCCULT BLOOD TEST, MODEL KT313 Epitope Diagnostics, Inc. KHE Class II 2005-10-03
K052464 TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST Roche Diagnostics Corp. LCP Class II 2005-09-30
K050448 CHROMOPEP PC, CHROMOPEP AT, MODELS 2.5 AND 5 Horiba Abx GGP Class II 2005-09-23
K051459 SYSMEX MODEL XE-2100DC AUTOMATED HEMATOLOGY ANALYZER Sysmex America, Inc. GKZ Class II 2005-09-23
K050421 MS 4/5 HEMATOLOGY ANALYZER Melet Schloesing Laboratories USA GKZ Class II 2005-08-31
K052101 C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C Roche Diagnostics KRZ Class II 2005-08-26
K051706 IQ BODY FLUIDS CONTROL Streck JPK Class II 2005-08-17
K051597 STRATUS CS D-DIMER Dade Behring, Inc. DAP Class II 2005-08-17
K050840 MODIFICATION TO DUET SYSTEM Bioview , Ltd. JOY Class II 2005-08-16
K051282 VENTANA IMAGE ANALYSIS SYSTEM - HER2/NEU Tripath Imaging, Inc. NOT Class II 2005-08-16
K051633 CD-CHEX PLUS BC Streck GGL Class II 2005-08-16
K050821 COAGCARE ANTICOAGULATION MANAGEMENT SYSTEM Zycare KQG Class II 2005-08-16
K051409 SLIVASURE Scandinavian Formulas, Inc. LED Class I 2005-08-08
K051200 HEMOGLOBIN A1C REAGENT SET Teco Diagnostics LCP Class II 2005-08-08
K051199 IPF (IMMATURE PLATELET FRACTION) PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER Sysmex America, Inc. GKZ Class II 2005-08-08
K051231 VERIFYNOW-P2Y12 ASSAY Accumetrics, Inc. JOZ Class II 2005-08-05
K051122 ITAG MHC TETRAMER CMV ASSAY Beckman Coulter, Inc. GKZ Class II 2005-08-01
K050436 MS 9/5 HEMATOLOGY ANALYZER Melet Schloesing Laboratories USA GKZ Class II 2005-07-27
K050574 AFINION HBALC Axis-Shield Poc AS LCP Class II 2005-07-22
K051215 CELL-DYN SAPPHIRE SYSTEM Abbott Laboratories GKZ Class II 2005-07-21
K051339 R&D CBC-4K PLUS RETICS HEMATOLOGY CONTROL R&D Systems, Inc. JPK Class II 2005-07-12
K050053 HEMORAM/AGGRAM ANALYZER Helena Laboratories JPA Class II 2005-07-11
K051054 VISULIZE FACTOR IX ANTIGEN KIT Affinity Biologicals, Inc. GGP Class II 2005-06-29
K050799 TRIAGE(R) D-DIMER CALIBRATION VERIFICATION CONTROLS; TRIAGE(R) D-DIMER CONTROLS Biosite Incorporated GGN Class II 2005-06-29
K050928 DADE THROMBIN REAGENT Dade Behring, Inc. KQJ Class II 2005-06-29
K050178 HBA1C ENZYMATIC ASSAY General Atomics LCP Class II 2005-06-28
K050236 FISHVIEW Applied Spectral Imaging , Ltd. LNJ Class II 2005-06-27
K051321 INVIEW Metrika, Inc. LCP Class II 2005-06-13
K050243 IMMEDIA PROTHROMBIN TIME SYSTEM Farallon Medial, Inc. JPA Class II 2005-06-06
K050721 ABX ERYTROL Horiba Abx JPK Class II 2005-06-01
K051040 HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR Medtronic Perfusion Systems JOX Class II 2005-05-24
K051072 BIO-RAD VARIANT NBS SICKLE CELL PROGRAM Bio-Rad Laboratories, Inc. GKA Class II 2005-05-12
K050012 VENTANA IMAGE ANALYSIS SYSTEM Tripath Imaging, Inc. NQN Class II 2005-05-06
K050014 HEMONIR TM Nir Diagnostics, Inc. GLY Class II 2005-05-05
K050589 RET-HE PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER Sysmex America, Inc. GKZ Class II 2005-05-04
K050661 HEMOSIL FACTOR II DEFICIENT PLASMA Instrumentation Laboratory CO GJT Class II 2005-05-02
K050544 HEMOSIL D-DIMER HS Instrumentation Laboratory CO DAP Class II 2005-04-26
K050719 ABX PENTRA DX 120: OPTION SPS EVOLUTION Horiba Abx GKZ Class II 2005-04-26
K050513 MDA B.30 bioMerieux, Inc. JPA Class II 2005-04-01
K050221 HEMOSIL SILICA CLOTTING TIME Instrumentation Laboratory CO GFO Class II 2005-03-30
K050235 IQ 200 URINE ANALYZER BODY FLUIDS MODULE Iris International, Inc. GKL Class II 2005-03-23
K043571 CRYOCHECK CLOT S Precision Biologic, Inc. GGP Class II 2005-03-18
K043451 BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATOR Hyphen Biomed GGN Class II 2005-03-17
K050278 HEMOSIL D-DIMER Instrumentation Laboratory CO DAP Class II 2005-03-10
K042884 DAKOCYTOMATION ER/PR PHARMDX KIT Dakocytomation California, Inc. MXZ Class II 2005-02-15
K050057 COULTER LH 750 HEMATOLOGY ANALYZER Beckman Coulter, Inc. GKZ Class II 2005-02-10
K050016 HEMOCHRON SIGNATURE ELITE International Technidyne Corp. JPA Class II 2005-02-10
K050063 PROSTATE-63 CANCER DIAGNOSTIC TEST Asymmetrx NTR Class I 2005-02-09
K043459 HEMOSIL FACTOR XII DEFICIENT PLASMA Instrumentation Laboratory CO GJT Class II 2005-02-09
K043215 FLOWCARE PLG CD4 REAGENT Beckman Coulter, Inc. GKZ Class II 2005-01-19
K043184 HEMOSIL RECOMBIPLASTIN Instrumentation Laboratory CO GJS Class II 2004-12-22
K042762 PEFAKIT APC-R FACTOR V LEIDEN Pentapharm , Ltd. GGW Class II 2004-12-22
K042760 PEFAKIT APC-R FACTOR V LEIDEN CONTROLS Pentapharm , Ltd. GGN Class II 2004-12-22
K042379 ANEMIAPRO SELF-SCREENER Biosafe Laboratories, Inc. KHG Class II 2004-12-15
K042687 ENZYGNOST F+2 (MONOCLONAL) TEST KIT Dade Behring, Inc. MIF Class II 2004-12-10
K042723 TRIGAGE PROFILER S.O.B. PANEL, MODEL 97300 Biosite Incorporated DAP Class II 2004-12-07
K043080 HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR Medtronic Vascular JOX Class II 2004-12-03
K042941 DADE BEHRING HEPARIN CALIBRATOR AND CONTROLS Dade Behring, Inc. GIZ Class II 2004-12-02
K042576 COATEST SP FVIII Instrumentation Laboratory CO GGP Class II 2004-12-02
K042333 CONTROL PLASMA N, PROC CONTROL PLASMA Dade Behring, Inc. GGN Class II 2004-12-01
K042919 FIBROTEK FIB R2 Diagnostics, Inc. GIS Class II 2004-11-29
K042890 TRIAGE D-DIMER TEST, MODEL 98100 Biosite Incorporated GHH Class II 2004-11-29
K041882 FLOWCARE SYSTEM Pointcare Technologies, Inc. GKZ Class II 2004-11-23

4,197 clearances in the Hematology panel. Data: openFDA.