meddevicedb.com FDA Device Reference

Review Panel

Hematology FDA 510(k) Clearances & Devices

Cleared Devices
4,197
Product Codes (page)
33
Latest Decision
1999-07-28

Clearances · page 12 of 42

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K984188 AUTOMATED CELLULAR IMAGING SYSTEM (ACIS) Chroma Vision Medical Systems, Inc. JOY Class II 1999-07-28
K984501 DADE BEHRING BFTII Dade Behring, Inc. JPA Class II 1999-07-28
K991065 CARESIDE PT Careside, Inc. GJS Class II 1999-07-26
K990618 VENTANA PGR PRIMARY ANTIBODY (CLONE 1A6) Ventana Medical Systems, Inc. MXZ Class II 1999-07-23
K990579 CRYOCHECK LA CHECK, MODELS CHK25-10 (25 X1.0 ML), CHK80-10 (80 X 1.0 ML) Precision Biologic GIR Class I 1999-07-23
K983203 IMMULITE EPO, MODEL #'S LKEPZ & LKEP1 Diagnostic Products Corp. GGT Class II 1999-07-12
K991605 CELL-DYN 3500 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION (IRF), CELL-DYN 3700 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION Abbott Laboratories GKZ Class II 1999-07-09
K991539 EXCELL 22 Mwi, Inc. GKZ Class II 1999-07-01
K984640 THERMAL ANGEL Estill Medical Technologies, Inc. BSB Class II 1999-07-01
K991142 CELL-DYN 1200 SYSTEM Abbott Laboratories GKZ Class II 1999-06-23
K991362 HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO) Morax JBD Class II 1999-06-21
K991321 PACIFIC HEMOSTASIS THROMBOSCREEN 200 Pacific Hemostasis KQG Class II 1999-06-21
K991402 DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE-CY5, CLONE UCHT1 & DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE, CLONE UCHT1 Dako Corp. GKZ Class II 1999-06-21
K991454 MOUSE IGG1 NEGATIVE CONTROLS Dako Corp. GKZ Class II 1999-06-21
K991876 SEDRITE PLUS ERYTHROCYTE SEDIMENTATION RATE R&D Systems, Inc. JPK Class II 1999-06-17
K991127 VARIANT II B-THALASSEMIA Bio-Rad JPD Class II 1999-06-10
K990814 CRYO CHECK FACTOR 2 DEFICIENT PLASMA, MODELS FDPO2-10, FDP02-15 Precision Biologic GJT Class II 1999-06-07
K991101 COAG-A-MATE MAX Organon Teknika Corp. GKP Class II 1999-06-01
K984141 GBACT + KIT Sienco, Inc. JBP Class II 1999-05-28
K983551 CRIT-SCAN II MONITOR In-Line Diagnostics Corp. GKF Class II 1999-05-27
K990566 TAS ANALYZER, MODEL 1009 Cardiovascular Diagnostics, Inc. JPA Class II 1999-05-14
K991070 COULTER Z2 ANALYZER Coulter Corp. GKL Class II 1999-05-11
K990957 ASTORIA-PACIFIC SPOTCHECK G6PD KIT 50 HR, MODEL 80-3000-13K Astoria-Pacific, Inc. JBL Class II 1999-05-11
K984269 DBEST OCCULT BLOOD TEST KIT Ameritek, Inc. KHE Class II 1999-05-11
K983475 HEMOCHRON RESPONSE International Technidyne Corp. KQG Class II 1999-05-03
K990327 RETICONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS Coulter Corp. GKZ Class II 1999-04-26
K990858 LYPOCHEK COAGULATION CONTROL, MODEL NOS. 787, 788, 789 Bio-Rad GGN Class II 1999-04-21
K990449 HEMOCHRON ELECTRONIC SYSTEM VERIFICATION TUBE International Technidyne Corp. JPA Class II 1999-04-13
K983892 COAGUCHEK PRO SYSTEM, APTT TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, APTT CONTROLS FOR COAGUCHEK PRO SYSTEM, COAGUCHEK P Roche Diagnostics/Boehringer Mannheim GmbH JPA Class II 1999-04-13
K990172 TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS WITH CYTO-STAT TETRACHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 MONOCLA Coulter Corp. GKZ Class II 1999-04-13
K990302 IL TEST LAC SCREEN (CLAIMS ADDED TO ACL FUTURA), IL TEST LAC CONFIRM (CLAIMS ADDAD TO ACL FUTURA) Instrumentation Laboratory CO GIR Class I 1999-04-08
K990352 COULTER AC T DIFF 2 ANALYZER Coulter Corp. GKZ Class II 1999-04-01
K990311 VEGA RETIC AUTOMATED HEMATOLOGY ANALYZER Abx Diagnostics GKZ Class II 1999-03-31
K980737 ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAY Nichols Institute Diagnostics GGT Class II 1999-03-23
K990184 AUTOMARQER Hamilton Thorne Research POV Class II 1999-03-19
K990296 CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25 X 1.0ML) Precision Biologic GJT Class II 1999-03-18
K984216 IMMUNO-TROL CONTROL CELLS Coulter Corp. JPK Class II 1999-03-16
K983379 GTI-PF4 ELISA Genetic Testing Institute LCO Class II 1999-03-09
K983032 CBC-5D HEMATOLOGY CONTROL R&D Systems, Inc. JPK Class II 1999-02-17
K990046 PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR VIII DEFICIENT PLASMA Pacific Hemostasis GJT Class II 1999-02-17
K983704 MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE Roche Diagnostic Systems, Inc. JCM Class II 1999-02-10
K984529 HEMOCHEK SAMPLE COLLECTION KIT Osborn Laboratories, Inc. LCP Class II 1999-01-28
K981174 CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML) AND FDP12-15 (1.5ML) Precision Biologicals, Inc. GJT Class II 1999-01-13
K981173 CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15 (1.5ML) Precision Biologicals, Inc. GJT Class II 1999-01-13
K982062 CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10 Precision Biologicals, Inc. GGW Class II 1999-01-13
K983898 BIOCLOT APC SENSITIVITY Biopool Intl., Inc. GGP Class II 1999-01-06
K983914 REAADS MONOCLONAL FREE PROTEIN S ANTIGEN TEST KIT Corgenix, Inc. GGP Class II 1998-12-22
K984268 VARIANT II HEMOGLOBIN A1C PROGRAM Bio-Rad LCP Class II 1998-12-17
K983473 FERTILMARQ TEST KIT Embryotech Laboratories, Inc. POV Class II 1998-12-17
K982426 SPIFE ALKALINE HEMOGLOBIN Helena Laboratories JBD Class II 1998-12-17
K983649 MAX-ACT Array Medical, Inc. JBP Class II 1998-12-11
K984099 QBC CENTRIFUGAL HEMATOLOGY CONTROL R&D Systems, Inc. JPK Class II 1998-12-10
K984131 COAGULATION CONTROL LEVEL 3 (ABNORMAL) Pacific Hemostasis GGC Class II 1998-12-01
K984130 COAGULATION CONTROL LEVEL 2 (ABNORMAL) Pacific Hemostasis GGC Class II 1998-12-01
K984129 COAGULATION CONTROL LEVEL 1 (NORMAL) Pacific Hemostasis GIZ Class II 1998-12-01
K983172 ACCU-BASE HEMOGLOBIN A1C SAMPLE COLLECTION KIT Diabetes Technologies, Inc. (Dti) LCP Class II 1998-11-30
K983726 GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL Genzyme Corp. LCP Class II 1998-11-25
K983253 PRECISION A1C HOME HBA1C SAMPLE COLLECTION KIT Medisense, Inc. LCP Class II 1998-11-20
K983460 STAR AUTOMATED MULTI-PARAMETRIC ANALYZER American Bioproducts Co. JPA Class II 1998-11-12
K982167 CYTO-STAT TRICHROME CD45-FITC/CD19-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME CD45-FITC/MSIGG1-RD1 Coulter Corp. GKZ Class II 1998-11-09
K982166 CYTO-STAT TRICHROME CD45-FITC/CD56-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME CD45-FITC/MSIGG1-RD1 Coulter Corp. GKZ Class II 1998-11-05
K983562 MASCOT MD HEMATOLOGY ANALYZER/ MODEL MD 700 Cdc Technologies, Inc. GKZ Class II 1998-11-03
K981950 SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500 Sysmex Corp. GKL Class II 1998-11-03
K983178 COAMATIC HEPARIN Instrumentation Laboratory CO KFF Class II 1998-11-03
K983107 VFE Ramco Laboratories, Inc. GGP Class II 1998-10-22
K982786 TRACCELL 2000 SLIDE MAPPING SYSTEM Accumed Intl., Inc. JOY Class II 1998-10-16
K982209 ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589 Sigma Diagnostics, Inc. GJA Class II 1998-10-15
K981709 COAGULATION FACTOR V DEFICIENT PLASMA Dade Behring, Inc. GJT Class II 1998-10-13
K972866 HEMOCHRON JR. MIOCROCOAGULATION CITRATED PT International Technidyne Corp. GJS Class II 1998-09-30
K980839 AVOCET PT Avocet Medical, Inc. JPA Class II 1998-09-30
K981711 SYSMEX AUTOMATED COAGULATION ANALYZER CA-500 Dade Behring, Inc. JPA Class II 1998-09-30
K981817 COAMATIC PLASMIN INHIBITOR Instrumentation Laboratory CO GGP Class II 1998-09-28
K982172 CYTO-STAT CD3-FITC/CD56-RDI MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT/COULTER CLONE MSIGGI-RD1/MSIGGI-FITC ISOTYPIC COL Coulter Corp. GKZ Class II 1998-09-24
K982802 BAYER ADVIA 60 HEMATOLOGY SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) Bayer Corp. GKZ Class II 1998-09-22
K981661 HEMAPROMPT Aerscher Diagnostics KHE Class II 1998-09-15
K973649 HEMOSITE TEST SYSTEM Gds Technology, LLC KHG Class II 1998-08-31
K981696 IL TEST PLASMIN INHIBITOR Instrumentation Laboratory CO GGP Class II 1998-08-27
K981568 MASCOT MD HEMATOLOGY ANALYZER, MODEL MD 800 Cdc Technologies, Inc. GKZ Class II 1998-08-21
K980885 SHIELD ACTIVATED FACTOR XII (ELISA) ASSAY Shield Diagnostics, Ltd. GGP Class II 1998-08-21
K981761 SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZER Sysmex Corp. GKL Class II 1998-08-14
K980888 GLYCACOR Exocell, Inc. LCP Class II 1998-08-13
K982301 MICRO21 WITH URINE SEDIMENT ANALYSIS Triangle Biomedical Sciences, Inc. JOY Class II 1998-08-07
K981815 HEPTRAC ELECTRONIC QUALITY CONTROL Medtronic Blood Management JPA Class II 1998-07-30
K980635 DAKO MOUSE ANTI-HUMAN B-CELL, CD19/RPE-CY5, CLONE HD37 Dako Corp. GKZ Class II 1998-07-22
K974343 DADE INNOVIN Dade Intl., Inc. GJS Class II 1998-07-22
K982231 STATUSFLOW R&D Systems, Inc. GKZ Class II 1998-07-20
K974799 HEMOCHRON JR GENERATION II, HEMOCHRON JR SIGNATURE International Technidyne Corp. JPA Class II 1998-07-07
K981479 IL TEST PT-FIBRINOGEN RECOMBINANT Instrumentation Laboratory CO GJS Class II 1998-07-07
K981342 ABBOTT CELL-DYN 4000 IMMUNOPIT (CD61) ASSAY Abbott Laboratories GKZ Class II 1998-06-29
K973365 AIC - CHEK (HBAIC-I) Express-Med, Inc. LCP Class II 1998-06-15
K981752 I-STAT COAGULATION CONTROL SET Biopool Intl., Inc. GGN Class II 1998-06-15
K980375 WINSCAN AUTOMATED IMAGING SYSTEM Applied Imaging Corp. JOY Class II 1998-06-09
K981555 DIASCREEN REAGENT STRIPS Chronimed, Inc. LJX Class I 1998-06-01
K974596 DIMERTEST LATEX ASSAY Agen Biomedical , Ltd. DAP Class II 1998-05-26
K981206 TAS RESULTS DATA ACQUISITION SYSTEM (TRAQS) Cardiovascular Diagnostics, Inc. GKP Class II 1998-05-26
K981200 IL TEST PLASMINOGEN Instrumentation Laboratory CO GGP Class II 1998-05-26
K980858 MULTITEST CD3/CD16+56/CD45/CD19 REAGENT AND MULTITEST IMK KIT LYSING SOLUTION Becton Dickinson Immunocytometry Systems GKZ Class II 1998-05-22
K974491 ACCU-CHEK A1C HEMOGLOBIN TEST Boehringer Mannheim Corp. LCP Class II 1998-05-13
K981427 STAT PROFILE M ANALYZER Nova Biomedical Corp. GKF Class II 1998-05-12
K981426 STAT PROFILE ULTRA F,G,H,I,J,K, AND L ANALYZERS Nova Biomedical Corp. GKF Class II 1998-05-12

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