meddevicedb.com FDA Device Reference

Review Panel

Hematology FDA 510(k) Clearances & Devices

Cleared Devices
4,197
Product Codes (page)
29
Latest Decision
1996-05-17

Clearances · page 15 of 42

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K960827 QBC ACCUTUBE(423406)/QBC AUTOREAD(424571) Becton Dickinson Diagnostic Instrument Systems GKZ Class II 1996-05-17
K960887 MOUSE ANTI-HUMAN CD4, T-CELL, HELPER/INDUCER/FITC & CD8, T-CELL, SUPPRESSOR/CYTOTOXIC/RPE Dako Corp. GKZ Class II 1996-05-17
K960776 MICRO21 WITH RETIC Triangle Biomedical Sciences, Inc. JOY Class II 1996-05-17
K950625 ORTHO-MUNE OK-COMBO CD40FITC/CD8-PE (OKT4A/OKT8) MONOCLONAL ANTIBODY (MURINE) Ortho Diagnostic Systems, Inc. GKZ Class II 1996-05-13
K951100 ORTHO-MUNE OK-COMBO CD3-FITC/CD19-PE (OKT3/OKB19A MONOLCLONAL ANTIBODY (MURINE) Ortho Diagnostic Systems, Inc. GKZ Class II 1996-05-13
K950568 ORTHO-MUNE OK-COMBO CD3-FITC/CD4-PE (OKT2/OKT4A) MONOCLONAL ANTIBODY (MURINE) Ortho Diagnostic Systems, Inc. GKZ Class II 1996-05-13
K953116 WHITE IRIS LEUKOCYTE DIFFERENTIAL ANALYZER Intl. Remote Imaging Systems GKZ Class II 1996-05-13
K950482 ORTHO-MUNE OK-COMVO CD3-FITC/CD8-PE (OKT 3/OKT8) MONOCLONAL ANTIBODY (MURINE) Ortho Diagnostic Systems, Inc. GKZ Class II 1996-05-10
K935720 ORTHO COUNT CALIBRATION KIT FOR ORTHO CYTORONABSOLUTE LASER FLOW CYTOMETRY SYSTEM Ortho Diagnostic Systems, Inc. GKZ Class II 1996-05-09
K960427 ABBOTT CELL-DYN 3500R SYSTEM Sequoia Turner Corp. GKZ Class II 1996-05-02
K954570 ORTHO IMMUNOCOUNT FLOW CYTOMETRY SYSTEM Ortho Diagnostic Systems, Inc. GKZ Class II 1996-04-30
K955355 VARIANT ALPHA-THALASSEMIA SHORT PROGRAM Bio-Rad GKA Class II 1996-04-26
K955013 NOVA CO-OXIMETER ANALYZER Nova Biomedical Corp. GLY Class II 1996-04-25
K955638 SYNTHAFAX APTT REAGENT Ortho Diagnostic Systems, Inc. GFO Class II 1996-04-23
K955450 PATHROMTIN SL Behring Diagnostics, Inc. GFO Class II 1996-04-19
K955115 VENOM TIEM REAGENT Medical Diagnostic Technologies, Inc. JCO Class II 1996-04-03
K960557 CALIBRATION VERIFICATION ASSESSMENT (CVA) Streck Laboratories, Inc. JPK Class II 1996-04-03
K955795 MULTI-CENTRIFUGE Novonx, Inc. GKG Class II 1996-03-29
K955909 MOUSE ANTI-HUMAN CD3, T-CELL, FITC & CD8, T-CELL(SUPPRESSOR/CYTOTOXIC) RPE Dako Corp. GKZ Class II 1996-03-28
K953643 HEMATIL 18 (H-18) Texas Intl. Laboratories, Inc. GKZ Class II 1996-03-22
K960471 TRI-COUNT 20 Hematronix, Inc. JPK Class II 1996-03-20
K960005 TRI-COURT 20-T Hematronix, Inc. JPK Class II 1996-03-19
K960090 CALCOFLUOR WHITE STAIN KIT Remel Co. JTS Class I 1996-03-19
K960095 BACTIDROP CALCOFLUOR WHITE Remel Co. JTS Class I 1996-03-19
K955843 TAS PTONE Cardiovascular Diagnostic Services GJS Class II 1996-03-18
K955720 AMAX CS-190 COAGULATION ANALYZER SYSTEM Sigma Diagnostics, Inc. JPA Class II 1996-03-13
K955724 KC 1A COAGULATION ANALYZER/SET Sigma Diagnostics, Inc. JPA Class II 1996-03-12
K954006 YELLOW IRIS URINALYSIS WORKSTATION W/IRISCOPE BODY FLUID ANALYSIS CAPABILITY Intl. Remote Imaging Systems GKL Class II 1996-03-12
K953598 SERIES 9100 PLUS AUTOMATED DIFFERENTIAL HEMATOLOGY ANALYZERS Serono Diagnostics, Inc. GKZ Class II 1996-03-11
K955735 KC 4A MICRO COAGULATION ANALYZER SET/SYSTEM Sigma Diagnostics, Inc. JPA Class II 1996-03-11
K952321 PORCINE FACTOR VIII;C REAGENT Helena Laboratories GGN Class II 1996-03-11
K954625 PROTHROMBIN TIME TEST CARD Cardiovascular Diagnostics, Inc. GJS Class II 1996-03-11
K955283 PRIMUS VARIANT SYSTEM PVS99 Primus Corp. GKA Class II 1996-03-01
K952126 AALTO SCIENTIFIC LIQUID CEREBROSPINAL FLUID CONTROLS LEVELS I AND II Aalto Scientific, Ltd. GGP Class II 1996-02-29
K955925 CBC-CAL PLUS HEMATOLOGY CALIBRATOR R&D Systems, Inc. KRX Class II 1996-02-29
K954688 FLOW-COUNT COULTER FLUOROSPHERES Coulter Corp. GKZ Class II 1996-02-29
K955738 BIOCLOT PROTEIN S Medical Diagnostic Technologies, Inc. GGP Class II 1996-02-29
K950342 TRITEST REAGENT CD3 FITC/CD19 PE/CD45 PERCP Becton Dickinson Immunocytometry Systems GKZ Class II 1996-02-20
K952725 MULTICHECK Radiometer America, Inc. GLY Class II 1996-02-20
K946055 TRITEST REAGENT CD3 FITC/CD4 PE/CD45 PERCP Becton Dickinson Immunocytometry Systems GKZ Class II 1996-02-20
K955921 A549 CELL CULTURE Viratest Intl., Inc. KIR Class I 1996-02-16
K952667 CHROM Z-HEPARIN, CAT. NO 5242 Helena Laboratories KFF Class II 1996-02-14
K952668 CHROM Z-F:VIII, CAT. NO. 5241 Helena Laboratories GGP Class II 1996-02-09
K952337 ROCHE UNIMATE 3/UNIMATE 5 HBA1C, HBA1C CALIBRATOR, HBA1C CONTROLS N & P Roche Diagnostic Systems, Inc. LCP Class II 1996-02-09
K955334 COULTER LINEARITY CONTROL Coulter Corp. JPK Class II 1996-02-08
K954898 PREDICTA ERYTHROPOIETIN KIT (MODIFICATION) Genzyme Corp. GGT Class II 1996-02-05
K955504 QBC ACCUREAD SYSTEM Becton Dickinson Diagnostic Instrument Systems GKZ Class II 1996-02-05
K955040 AT-III CONTROL PLASMA KIT American Bioproducts Co. GGC Class II 1996-01-31
K952666 CHROM Z-PROTEIN C, CAT. NO. 5243 Helena Laboratories GGP Class II 1996-01-30
K955016 4C PLUS COULTER CELL CONTROL Coulter Corp. JPK Class II 1996-01-30
K954437 THROMBELASTOGRAPH COAGULATION ANALYZER 3000S Haemoscope Corp. GKP Class II 1996-01-30
K945212 MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD4, CLONE MT310, FITC-CONJUGATED, (ANTI-CD4/FITC, MT310) RPE-CONJUGATED, (ANTI-CD4/ Dako Corp. GKZ Class II 1996-01-26
K954997 CENTOCOR AGGRESTAT, COLLAGEN REAGENT, CONTROL REAGENT Centocor, Inc. JOZ Class II 1996-01-24
K952515 COACUTE ANTITHROMBIN R CHROMOGENIC ASSAY Chromogenix AB JBQ Class II 1996-01-23
K951823 CRYO CHECK LOW FIBRINOGEN CONTROL Precision Biologicals, Inc. GGN Class II 1996-01-03
K950918 CD3 FITC/CD4 R-PE MONOCLONAL ANTIBODY COMBINATION Caltag Laboratories, Inc. GKZ Class II 1995-12-21
K951073 CD3 TRI-COLOR/CD4 R-PE/CD8 FITC MONOCLONAL ANTIBODY COMBINATION Caltag Laboratories, Inc. GKZ Class II 1995-12-21
K950916 CD3 FITC/CD8 R-PE MONOCLONAL ANTIBODY COMBINATION Caltag Laboratories, Inc. GKZ Class II 1995-12-21
K950917 CD3 FITC/CD8 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION Caltag Laboratories, Inc. GKZ Class II 1995-12-21
K950919 CD3 FITC/CD4 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION Caltag Laboratories, Inc. GKZ Class II 1995-12-20
K945756 IMAGN(TM) 2000 SYSTEM Buckman Co., Inc. GKZ Class II 1995-12-19
K952669 CHROM Z-PLASMINOGEN, CAT. NO. 5244 Helena Laboratories GGP Class II 1995-12-07
K953981 SYNTHASIL APTT REAGENT Ortho Diagnostic Systems, Inc. GFO Class II 1995-11-30
K952625 COAGUCHEK SYSTEM Boehringer Mannheim Corp. JPA Class II 1995-11-21
K953302 FACS LOADER SYSTEM Becton Dickinson Immunocytometry Systems GKZ Class II 1995-11-20
K952727 MRC-5 CELL CULTURE VIAL Viratest Intl., Inc. KIR Class I 1995-11-20
K954048 VARIANT HEMOGLOBINOPATHY PROGRAM Bio-Rad GKA Class II 1995-11-20
K952514 COACUTE HEPARIN Chromogenix AB KFF Class II 1995-11-20
K933878 ZYMMUNE(TM) CD4/CD8 CELL MONITORING KIT Intracel Corp. GKZ Class II 1995-11-14
K951943 CHROM Z CHROMOGENIC ASSAYS Helena Laboratories JBQ Class II 1995-11-13
K954017 ASSERACHROM FREE PROTEIN S KIT American Bioproducts Co. GGP Class II 1995-11-13
K954040 ASSERACHROM TOTAL PROTEIN S KIT American Bioproducts Co. GGP Class II 1995-11-13
K952623 CRYO CHECK LUPUS PLASMA Precision Biologicals, Inc. GGC Class II 1995-11-06
K943225 COAMATIC FACTOR VIII Pharmacia Hepar, Inc. GGP Class II 1995-11-06
K954188 OPTICLONE IGG1 FITC/IGG2A PE ISOTYPIC CONTROL Immunotech Corp. GKZ Class II 1995-11-03
K953519 MICROSPIN 24 Vulcon Technologies GKF Class II 1995-11-03
K951891 ACL FUTURA COAGULATION SYSTEM Instrumentation Laboratory CO JPA Class II 1995-11-03
K953870 ACTTRAC ELECTRONIC CONTROL DEVICE FOR THE ACT & ACT II COAGULATION INSTRUMENTS Medtronic Vascular GKN Class II 1995-10-31
K952624 CRYO CHECK ABNORMAL REFERENCE CHECK I & II Precision Biologicals, Inc. GGC Class II 1995-10-30
K952622 CRYO CHECK NORMAL HUMAN REFERENCE PLASMA Precision Biologicals, Inc. GGN Class II 1995-10-30
K951072 PROTIME MICROCOAGULATION SYSTEM International Technidyne Corp. GKP Class II 1995-10-27
K945642 AGEN DIMERTEST GOLD EIA Agen Biomedical , Ltd. GHH Class II 1995-10-25
K945855 A-FACT, ABNORMAL FACTOR ASSAY CONTROL George King Bio-Medical, Inc. GGN Class II 1995-10-24
K945854 B-FACT, BORDERLINE FACTOR ASSAY CONTROL George King Bio-Medical, Inc. GGN Class II 1995-10-24
K946335 OPTICLONE(TM CD3 FITC/CD19 PE MONOCLONAL ANTIBODIES Immunotech, Inc. GKZ Class II 1995-10-20
K951820 THROMBOPLASTIN-LI REAGENT Helena Laboratories GJS Class II 1995-10-20
K945857 PROTEIN C DEFICIENT PLASMA George King Bio-Medical, Inc. GJT Class II 1995-10-20
K945677 IL682, CO-OXIMETER Instrumentation Laboratory CO GKR Class II 1995-10-20
K951496 CELL-DYN 3500 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER Abbott Laboratories GKZ Class II 1995-10-19
K940003 VOLUMET CD4 + AND CD8 + T LYMPHOCYTE COUNT TEST KIT Buckman Co., Inc. GKZ Class II 1995-10-19
K953448 ROCHE COBAS MICROS HEMATOLOGY ANALYZER Roche Diagnostic Systems, Inc. GKZ Class II 1995-10-13
K952308 COULTER Z 1 Coulter Corp. GKL Class II 1995-10-06
K954137 QBC CENTRIFUGAL HEMATOLOGY CONTROL R&D Systems, Inc. JPK Class II 1995-10-06
K952608 MDA SIMPLASTIN LS Organon Teknika Corp. GJS Class II 1995-10-06
K953340 QBC ACCUTUBE Becton Dickinson Diagnostic Instrument Systems GKZ Class II 1995-10-05
K945856 POSITIVE LUPUS ANTICOAGULANT PLASMA George King Bio-Medical, Inc. GGC Class II 1995-10-05
K954018 AVL OMNI ANALYZER Avl Scientific Corp. GKR Class II 1995-10-05
K953221 ABBOTT VISION HEMOGLOBIN (MODIFICATION) Abbott Laboratories KHG Class II 1995-09-29
K943520 HEPARIN CONTROL KIT American Bioproducts Co. KFF Class II 1995-09-26
K943514 THE HEPANORM HBPM/LMWH KIT American Bioproducts Co. KFF Class II 1995-09-26

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