meddevicedb.com FDA Device Reference

Review Panel

Hematology FDA 510(k) Clearances & Devices

Cleared Devices
4,197
Product Codes (page)
31
Latest Decision
2002-03-07

Clearances · page 10 of 42

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K013168 IMUBIND PLASMA PAI-1 ELISA,MODEL 822 American Diagnostica, Inc. GGP Class II 2002-03-07
K020060 ASTOFLO Nats Corp. BSB Class II 2002-03-05
K020023 DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, ANTIBODY FOR IMMUNOENZYMATIC STAINING Dako Corp. MXZ Class II 2002-02-28
K013148 BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88) Biogenex Laboratories MYA Class II 2002-02-28
K014203 ABX MICROS 60 HEMATOLOGY ANALYZER Abx Diagnostics GKX Class II 2002-02-28
K020234 A1CNOW FOR RX HOME USE Metrika, Inc. LCP Class II 2002-02-15
K020235 A1CNOW FOR PROFESSIONAL USE Metrika, Inc. LCP Class II 2002-02-15
K020138 STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARDS, STAT-SITE MHGB CODE WAY, MODELS 90090 Gds Technology KHG Class II 2002-02-11
K014028 CARESIDE APTT Careside Hemotology, Inc. GFO Class II 2002-02-08
K020109 SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL Sigma Diagnostics, Inc. GGC Class II 2002-02-06
K020229 R & D BODY FLUID CONTROL R&D Systems, Inc. JPK Class II 2002-02-06
K014008 HEMOCHRON JR. CITRATE APTT CUVETTE Itc, Inc. GFO Class II 2002-01-24
K013898 R&D RET-LINE KIT R&D Systems, Inc. JPK Class II 2002-01-22
K013465 ACCU-BASE HEMOGLOBIN A1C SAMPLE COLLECTION KIT Diabetes Technologies, Inc. LCP Class II 2002-01-22
K013155 DADE THROMBOPLASTIN C PLUS Dade Behring, Inc. GJS Class II 2002-01-18
K013078 ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752 Helena Laboratories JBP Class II 2002-01-10
K013549 SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971 Sigma Diagnostics, Inc. DAP Class II 2001-12-26
K013842 IMMUNO-TROL LOW CELLS Beckman Coulter, Inc. JPK Class II 2001-12-13
K013708 REFERENCE CHECK, CATALOG NUMBER-RCN-10 Precision Biologic GIZ Class II 2001-12-10
K013545 SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221 Sigma Diagnostics, Inc. DAP Class II 2001-11-15
K011852 DIMENSION HAIC ASSAY, MODEL DF105 Dade Behring, Inc. LCP Class II 2001-11-15
K013544 SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096 Sigma Diagnostics, Inc. DAP Class II 2001-11-15
K013114 BCS SYSTEM Dade Behring, Inc. JPA Class II 2001-11-09
K013316 SICKLE-CHEX Streck Laboratories, Inc. GHM Class II 2001-11-06
K011933 GLYCOSAL II HBA 1C TEST Provalis Diagnostics , Ltd. LCP Class II 2001-11-02
K012410 INFINITY HBA KIT, MODELS 537-A, 537-B Sigma Diagnostics, Inc. LCP Class II 2001-10-26
K011337 ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA) Accumetrics, Inc. JOZ Class II 2001-10-16
K012525 THERMO DMA FRUCTOSAMINE ASSAY, MODEL 7500-135/235 Thermo Dma, Inc. LCP Class II 2001-10-04
K012372 SYSMEX UF-50 Sysmex Corp. LKM Class II 2001-09-28
K012723 PLATELETWORKS Helena Laboratories JOZ Class II 2001-09-28
K012934 CELL-DYN 3200 SYSTEM WITH ABSOLUTE AND PERCENT RETICULOCYTE Abbott Laboratories GKZ Class II 2001-09-28
K012904 ADVIA 120 HEMATOLOGY SYSTEM, CYANIDE-FREE HIGH DETERMINATION Bayer Diagnostics Corp. GKZ Class II 2001-09-21
K012352 SQA, SPERM QUALITY ANALYZER Medical Electronic Systems, LLC POV Class II 2001-09-21
K012768 HEMOSIL RECOMBI PLASTIN Instrumentation Laboratory CO GJS Class II 2001-09-18
K012722 LYPHOCHEK COAGULATION CONTROL LEVEL 1, LYPHOCHEK COAGULATION LEVEL 2, LYPHOCHEK COAGULATION LEVEL 3, MODELS 781,782,783 Bio-Rad GGN Class II 2001-09-18
K011434 G7 AUTOMATED HPLC ANALYZER Tosoh Medics, Inc. LCP Class II 2001-09-18
K012103 BANDVIEW SYSTEM Applied Spectral Imaging , Ltd. LNJ Class II 2001-09-14
K012386 ACTICLOT PROTEIN S, MODEL 843L American Diagnostica, Inc. GGP Class II 2001-09-14
K010750 PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560 Fisher Diagnostics GGN Class II 2001-09-07
K012422 K-ASSAY D-DIMER CONTROLS Kamiya Biomedical Co. GGC Class II 2001-08-21
K011679 FERTILMARQ HOME DIAGNOSTIC SCREENING TEST KIT FOR MALE INFERTILITY Embryotech Laboratories, Inc. POV Class II 2001-08-15
K011665 BCT SYSTEM Dade Behring, Inc. JPA Class II 2001-08-09
K012031 MODIFICATION TO THERMAL ANGEL Estill Medical Technologies, Inc. BSB Class II 2001-07-26
K011235 SYSMEX AUTOMATED COAGULATION ANALYZER / MODEL # CA-1500 Dade Behring, Inc. JPA Class II 2001-07-20
K010748 SYNCHRON SYSTEMS HEMOGLOBIN A1C REAGENT Beckman Coulter, Inc. LCP Class II 2001-07-10
K011342 COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632 Beckman Coulter, Inc. GKZ Class II 2001-07-09
K010599 PROTIME MICROCOAGULATION SYSTEM / PROTIME 3 CUVETTE International Technidyne Corp. GJS Class II 2001-07-02
K011410 PARA 5X Streck Laboratories, Inc. JPK Class II 2001-06-26
K011424 IL TEST PROS Instrumentation Laboratory CO GGP Class II 2001-06-25
K002885 DADE PFA-100 PLATELET FUNCTION ANALYZER MODEL-100, DADE PFA COLLEGEN/EPINEPHRINE TEST CARTRIDE, DADE PFA COLLEAGEN /ADP Dade Behring, Inc. JOZ Class II 2001-06-21
K011389 HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL) Canterbury Health Laboratories JCM Class II 2001-06-21
K010455 ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN Diagnostica-Stago KFF Class II 2001-06-07
K010953 CELL-DYN 4000 IMMUNO T-CELL (CD3/4/8) ASSAY Abbott Laboratories GKZ Class II 2001-06-06
K010963 STA-LIATEST FREE PROTEIN S TEST KIT Diagnostica Stago, Inc. GGP Class II 2001-06-06
K010193 HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS International Technidyne Corp. KFF Class II 2001-06-06
K011143 TINA-QUANT D-DIMER TEST SYSTEM Roche Diagnostics Corp. GHH Class II 2001-05-29
K002948 K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT Kamiya Biomedical Co. DAP Class II 2001-05-18
K001699 RUBICON PROTHROMBIN TIME MONITORING SYSTEM Lifescan, Inc. GJS Class II 2001-05-15
K010470 R & D 4K RETIC R&D Systems, Inc. JPK Class II 2001-05-11
K010494 SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 Dade Behring, Inc. JPA Class II 2001-05-01
K010379 IL TEST FREE PROTEIN S Instrumentation Laboratory CO GGP Class II 2001-04-13
K010765 COULTER HMX ANALYZER, MODEL 6605523, COULTER HMX WITH AUTOLOADER, MODEL 6605526 Beckman Coulter, Inc. GKZ Class II 2001-04-13
K010324 STA-QUALITY HBPM/LMWH KIT Diagnostica Stago, Inc. GGN Class II 2001-04-09
K010350 STA -CALIBRATOR HBPM/LMWH KIT Diagnostica Stago, Inc. GGN Class II 2001-04-09
K010461 ADVIA RETIC PLUS R&D Systems, Inc. JPK Class II 2001-04-03
K010598 SYNOVIALSCOPICS, SYNOVIAL FLUID CONTROL Quantimetrix Corp. JPK Class II 2001-03-23
K010158 THROMBOMAX-HS WITH CALCIUM, MODEL T6540 Sigma Diagnostics, Inc. GGO Class II 2001-03-22
K002706 ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON COBAS INTEGRA; ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON HITACHI Roche Diagnostics Corp. DAP Class II 2001-03-16
K010409 CBC-SF R&D Systems, Inc. JPK Class II 2001-03-16
K003301 DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER CellaVision AB JOY Class II 2001-03-15
K003267 SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A Sigma Diagnostics, Inc. DAP Class II 2001-03-15
K003329 SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217 Sigma Diagnostics, Inc. GGC Class II 2001-03-01
K003328 ACCUCLOT CONTROL I, MODEL A4089 Sigma Diagnostics, Inc. GIZ Class II 2001-03-01
K002756 EASE-A-CULT Diagnostica, Inc. KHE Class II 2001-02-23
K003870 THROMBOREL S Dade Behring, Inc. GJS Class II 2001-02-20
K003767 ASSERACHROM HPIA TEST KIT Diagnostica Stago, Inc. LCO Class II 2001-02-12
K010066 5C-ES CELL CONTROL, MODELS 7547191, 7547192 Beckman Coulter, Inc. JPK Class II 2001-02-07
K010064 4C-ES CELL, MODELS 7547187, 7547188, 7547189, 7547190 Beckman Coulter, Inc. JPK Class II 2001-02-07
K003796 ADVIA 120 HEMATOLOGY Bayer Corp. GKZ Class II 2001-02-05
K002642 MINIQUANT D-DIMER, MODEL 1447 Biopool Intl., Inc. DAP Class II 2001-02-05
K002930 INSTACCULT Medtek Diagnostics, LLC KHE Class II 2001-01-22
K003991 CD-CAL PLUS CALIBRATOR R&D Systems, Inc. KRX Class II 2001-01-16
K002457 !NSURE FECAL OCCULT BLOOD TEST Enterix, Inc. KHE Class II 2001-01-12
K003874 CBC-4K HEMATOLOGY CONTROL R&D Systems, Inc. JPK Class II 2001-01-12
K003677 ABX PENTRA 60C+ HEMATOLOGY ANALYZER Abx Diagnostics GKZ Class II 2000-12-26
K003280 VARIANT II TOTAL GHB Bio-Rad LCP Class II 2000-12-19
K003120 MODIFICATION TO INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN A1C Roche Diagnostics Corp. LCP Class II 2000-12-18
K003534 PENTRA 5D R&D Systems, Inc. JPK Class II 2000-12-01
K003030 LYPHOCHEK HEMOGLOBIN ALC LINEARITY SET Bio-Rad GGM Class II 2000-11-29
K003359 COLOSCREEN-ES Helena Laboratories KHE Class II 2000-11-27
K002080 BEHRING COAGULATION SYSTEM, MODEL BCS Dade Behring, Inc. JPA Class II 2000-11-16
K003208 R & D 3K RETIC R&D Systems, Inc. JPK Class II 2000-11-07
K002646 ABX MICROS CRP Abx Diagnostics GKZ Class II 2000-10-26
K002467 COALIZA PROTEIN S-FREE Instrumentation Laboratory CO GGP Class II 2000-10-13
K002350 REFACTO LABORATORY STANDARD The Genetics Institute GGP Class II 2000-10-05
K000885 DRX HBA1C - FOR PRESCRIPTION HOME USE Metrika, Inc. LCP Class II 2000-09-26
K002541 PROTEIN C REAGENT Dade Behring, Inc. GGP Class II 2000-09-26
K002177 THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIES Haemoscope Corp. JPA Class II 2000-09-14
K002511 FETALTROL Trillium Diagnostics, LLC JPK Class II 2000-09-11
K994349 COAGUCHEK S SYSTEM, MODEL 2138280 Roche Diagnostics Corp. JPA Class II 2000-09-06

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