meddevicedb.com FDA Device Reference

Review Panel

Hematology FDA 510(k) Clearances & Devices

Cleared Devices
4,197
Product Codes (page)
33
Latest Decision
1998-05-12

Clearances · page 13 of 42

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K981425 STAT PROFILE ULTRA A, B, C, D, AND E ANALYZERS Nova Biomedical Corp. GKF Class II 1998-05-12
K980671 COLOSCREEN-ES Helena Laboratories KHE Class II 1998-05-12
K974711 COAMATIC PLASMINOGEN Instrumentation Laboratory CO GGP Class II 1998-05-01
K973741 BAIR HUGGER BLOOD/FLUID WARMER Augustine Medical, Inc. BSB Class II 1998-04-30
K981255 SIGMA DIAGNOSTICS ACCUCLOT CONTROL III Sigma Diagnostics, Inc. GGN Class II 1998-04-29
K981254 SIGMA DIAGNOSTICS ACCUCLOT CONTROL II Sigma Diagnostics, Inc. GGN Class II 1998-04-29
K981248 SIGMA DIAGNOSTICS ACCUCLOT CONTROL I Sigma Diagnostics, Inc. GGN Class II 1998-04-29
K981178 THROMBOLYTIC ASSESSMENT SYSTEM LOW RANGE HEPARIN MANAGEMENT TEST CONTROLS Cardiovascular Diagnostics, Inc. GGN Class II 1998-04-27
K980614 ABBOTT CELL-DYN 3000 SERIES HEMATOLOGY SYSTEMS Abbott Laboratories GKZ Class II 1998-04-24
K980875 IL TEST PROTEIN C Instrumentation Laboratory CO GGP Class II 1998-04-21
K981038 COAMATIC FACTOR VIII Instrumentation Laboratory CO GGP Class II 1998-04-16
K974776 MDA D-DIMER Organon Teknika Corp. DAP Class II 1998-04-16
K980982 AVOCET SYSTEM LIQUID CONTROL LEVEL 1 AND LEVEL 2 Avocet Medical, Inc. GGN Class II 1998-04-16
K980314 FETAL D TECTION KIT Biopool Intl., Inc. LIM Class II 1998-04-08
K980499 IL TEST ANTITHROMBIN Instrumentation Laboratory CO JBQ Class II 1998-04-02
K980242 IL TEST HEPARIN Instrumentation Laboratory CO KFF Class II 1998-03-19
K974360 MULTITEST CD3/CD8/CD45/CD4 Becton Dickinson Immunocytometry Systems GKZ Class II 1998-03-11
K974805 CO-STAT(TM) END TIDAL BREATH ANALYZER Natus Medical, Inc. GHS Class II 1998-03-11
K973819 VIDAS D-DIMER (DD) ASSAY Biomerieux Vitek, Inc. DAP Class II 1998-03-10
K974566 MDA SIMPLASTIN HTF Organon Teknika Corp. GJS Class II 1998-02-24
K973483 FACSCOMP SOFTWARE AND CALIBRITE BEADS FOR USE IN FLOW CYTOMETER INSTRUMENT SET Becton Dickinson Immunocytometry Systems GKZ Class II 1998-02-17
K974569 COAGUCHEK SYSTEM, COAGUCHEK SYSTEM FOR PROTHROMBIN TIME SELF TESTING Boehringer Mannheim Corp. JPA Class II 1998-01-09
K974110 IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT Beckman Instruments, Inc. JBQ Class II 1997-12-24
K973995 RANDOX BILIRUBIN Randox Laboratories, Ltd. GIG Class II 1997-12-08
K971205 TRI TEST REAGENT CD4 FIT C/CD8 PE/CD3 PERCP WITH TRUCOUNT ABSOLUTE COUNT TUBES Becton Dickinson Immunocytometry Systems GKZ Class II 1997-12-01
K971110 TRITEST REAGENT CD3 FITC/CD16+CD56 PE/CD45 PERCP;WITH TRUCOUNT ABSOLUTE COUNT TUBES Becton Dickinson Immunocytometry Systems GKZ Class II 1997-11-25
K973696 SYNCHRON SYSTEM HEMOGLOBIN ALC REAGENT Beckman Instruments, Inc. LCP Class II 1997-11-24
K970326 TRITEST REAGENT CD3 FITC/CD8 PE/CD45 PERCP;WITH TRUCOUNT ABSOLUTE COUNT TUBES Becton Dickinson Immunocytometry Systems GKZ Class II 1997-11-21
K965053 TRITEST REAGENT CD3 FITC/CD4 PE/CD45 PERCP; TRUCOUNT ABSOLUTE COUNT TUBES Becton Dickinson Immunocytometry Systems GKZ Class II 1997-11-21
K972831 HEMOCHRON CITRATE APTT International Technidyne Corp. GFO Class II 1997-11-20
K970505 DADE PFA-100 PLATELET FUNCTION ANALYZER/PFA COLLAGEN/EPINEPHRINE TEST CARTRIDGE/PFA COLLAGEN/ADP TEST CARTRIDGE/ Dade Intl., Inc. JOZ Class II 1997-11-17
K973050 MICRO21 WITH WBC ESTIMATE Triangle Biomedical Sciences, Inc. JOY Class II 1997-11-07
K973306 IL TEST APTT-SP Instrumentation Laboratory CO GFO Class II 1997-11-04
K972696 IL TEST D-DIMER Instrumentation Laboratory CO DAP Class II 1997-11-04
K973274 ACCUCOLOR HIGH CALIBRATOR (A3089) Sigma Diagnostics, Inc. GIZ Class II 1997-10-31
K973634 COULTER AC.T DIFF ANALYZER Coulter Corp. GKZ Class II 1997-10-29
K972867 CRAFT DUO-VAC SUCTION UNIT, CRAFT SUCTION UNIT Rocket Medical Plc ICX Class I 1997-10-24
K970742 TRITEST CD3 FITC/CD19 PE/CD45 PERCP REAGENT WITH TRUCOUNT ABSOLUTE COUNT TUBES Becton Dickinson Immunocytometry Systems GKZ Class II 1997-10-22
K972763 HEMAPROMPT Aerscher Diagnostics KHE Class II 1997-10-20
K972260 CS-400 COAGULATION ANALYZER SYSTEM (A1208) Sigma Diagnostics, Inc. JPA Class II 1997-10-20
K971985 N-ASSAY TIA PLASMINOGEN TEST KIT Crestat Diagnostics, Inc. GGP Class II 1997-10-20
K972257 N-ASSAY TIA ANTITHROMBIN III TEST KIT Crestat Diagnostics, Inc. DDQ Class II 1997-10-20
K972796 SIGMA DIAGNOSTICS THROMBOMAX WITH CALCIUM Sigma Diagnostics, Inc. GJS Class II 1997-10-10
K971858 SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A) Sigma Diagnostics, Inc. KQJ Class II 1997-10-09
K972342 REAADS PROTEIN C ANTIGEN TEST KIT Reaads Medical Products, Inc. GGP Class II 1997-10-06
K971935 B&D ACTIVATED CLOTTING TIME (ACT) TEST TUBES BD-C101 (DIATOMACEOUS EARTH) AND BD-K101 (KAOLIN) B & D Corp. JBP Class II 1997-10-01
K973212 FRESH CELLS WI-38 Diagnostic Hybrids, Inc. KIR Class I 1997-09-25
K973214 FRESH CELLS HFF Diagnostic Hybrids, Inc. KIR Class I 1997-09-25
K973213 FRESH CELLS LLC-MK2 Diagnostic Hybrids, Inc. KIR Class I 1997-09-25
K973209 FRESH CELLS VERO Diagnostic Hybrids, Inc. KIR Class I 1997-09-25
K973211 FRESH CELLS MV1LU Diagnostic Hybrids, Inc. KIR Class I 1997-09-25
K973210 FRESH CELLS NCI H292 Diagnostic Hybrids, Inc. KIR Class I 1997-09-25
K973143 UNIVERSAL REAGENT FACTOR XII (TWELVE) DEFICIENT PLASMA Universal Reagents, Inc. GGP Class II 1997-09-25
K964406 AUTOMATED MULTI-POINT BLOOD VOLUME ANALYZER Daxor Corporation JWO Class II 1997-09-25
K972265 A1C 2.2 PLUS - AUTOMATED GLYCOHEMOGLOBIN ANALYZER Tosoh Medics, Inc. LCP Class II 1997-09-25
K972969 QUICK-DRAW CAPILLARY WHOLE BLOOD COLLECTION SYSTEM Innovative Medical Technologies, Inc. GIO Class I 1997-09-22
K971508 RHMK II CELL CULTURE, AN EXPANDED PRIMARY RHESUS MONKEY KIDNEY CELL CULTURE Bio-Whittaker, Inc., A Cambrex Co. KIR Class I 1997-09-17
K971470 MICRO21 WITH CEREBROSPINAL FLUID Triangle Biomedical Sciences, Inc. JOY Class II 1997-09-16
K972354 ABBOTT CELL-DYN 3200 SYSTEM Abbott Laboratories GKZ Class II 1997-09-16
K972316 OPUS D-DIMER Behring Diagnostics, Inc. GHH Class II 1997-09-09
K971919 EZCHEK/HBA BLOOD COLLECTION KIT Flexsite Diagnostics, Inc. LCP Class II 1997-09-05
K971219 CRYO CHECK INR VALIDATION SET Precision Biologicals, Inc. GGN Class II 1997-08-29
K971998 ADVIA 120 HEMATOLOGY SYSTEM, IN VITRO DIAGNOSTIC SYSTEM Bayer Corp. GKL Class II 1997-08-29
K972414 FRESHCELLS Diagnostic Hybrids, Inc. KIR Class I 1997-08-29
K970836 TRUCOUNT ABSOLUTE COUNT TUBES/COUNTING CONTROL BEADS Becton Dickinson Immunocytometry Systems GKZ Class II 1997-08-26
K971736 SYSMEX IMMATURE RETICULOCYTE FRACTION (IRF) PARAMETER Sysmex Corp. GKZ Class II 1997-08-26
K971222 CRYO CHECK APC RESISTANT PLASMA Precision Biologicals, Inc. GGN Class II 1997-08-19
K971519 ASSERACHROM TPA TEST KIT American Bioproducts Co. GGP Class II 1997-08-19
K964689 TRACCELL 2000 SLIDE MAPPING SYSTEM Accumed Intl., Inc. JOY Class II 1997-08-18
K972627 PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR V DEFICIENT PLASMA (THROMBOSDREEN BRAND) (100056) Pacific Hemostasis GJT Class II 1997-08-13
K972005 REAADS VON WILLEBRAND FACTOR ANTIGEN TEST KIT Reaads Medical Products, Inc. GGP Class II 1997-08-13
K972482 REAADS PROTEIN S ANTIGEN TEST KIT Reaads Medical Products, Inc. GGP Class II 1997-08-13
K972209 SPECTROLYSE HEPARIN (ANTI-IIA) Medical Diagnostic Technologies, Inc. KFF Class II 1997-08-12
K971152 ABBOTT CELL-DYN 4000 IMMATURE RETICULOCYTE FRACTION (IRF) Abbott Laboratories GKZ Class II 1997-08-12
K972144 SIGMA DIAGNOSTICS ACCUCOLOR ANTITHROMBIN III Sigma Diagnostics, Inc. JBQ Class II 1997-07-25
K972116 VON WILLEBRAND REAGENT Behring Diagnostics, Inc. GGP Class II 1997-07-25
K972170 ESR CONTROL-HC HEMATOLOGY ERYTHROCYTE SEDIMENTATION R&D Systems, Inc. JPK Class II 1997-07-24
K972172 ESR CONTROL-M HEMATOLOGY ERYTHROCYTE SEDIMENTATION R&D Systems, Inc. JPK Class II 1997-07-24
K971223 CRYO CHECK FACTOR V DEFICIENT PLASMA Precision Biologicals, Inc. GJT Class II 1997-07-22
K972404 VACUTAINER BRAND SAFETY BLOOD COLLECTION ASSEMBLY(MULTIPLE) Bd Becton Dickinson Vacutainer Systems Preanalytic KJA Class I 1997-07-22
K971226 CRYO CHECK FACTOR IX DEFICIENT PLASMA Precision Biologicals, Inc. GJT Class II 1997-07-18
K971227 CRYO CHECK FACTOR X DEFICIENT PLASMA Precision Biologicals, Inc. GJT Class II 1997-07-18
K971224 CRYO CHECK FACTOR VII DEFICIENT PLASMA Precision Biologicals, Inc. GJT Class II 1997-07-17
K971225 CRYO CHECK FACTOR VIII DEFICIENT PLASMA Precision Biologicals, Inc. GJT Class II 1997-07-17
K972288 FACTOR DEFICIENT PLASMAS - FACTOR IX (9) Universal Reagents, Inc. GGP Class II 1997-07-14
K972286 FACTOR DEFICIENT PLASMAS - FACTOR XI (11) Universal Reagents, Inc. GJT Class II 1997-07-14
K951459 ORTHO-MUNE OKT 4A (CD4) - MONOCLONAL ANTIBODY (MURINE) FITC CONJUGATE Ortho Diagnostic Systems, Inc. GKZ Class II 1997-07-14
K971469 COULTER ACT TRON CELL CONTROL Coulter Corp. JPK Class II 1997-06-30
K964728 STA-LIATEST D-DI TEST KIT American Bioproducts Co. DAP Class II 1997-06-26
K964716 STA LIATEST CONTROL [N]+[P] KIT American Bioproducts Co. GGN Class II 1997-06-26
K964974 MOUSE ANTI-HUMAN CD45, LEUCOCYTE COMMON ANTIGEN (LCA)/FITC AND CD14, MONOCYTE/RPE Dako Corp. GKZ Class II 1997-06-24
K971428 COAGULATION CONTROL PLASMA(ABNORMAL)LEVEL 0 Pacific Hemostasis GGN Class II 1997-06-17
K971976 DIASCREEN REAGENT STRIPS Dia-Screen Corp. LJX Class I 1997-06-17
K962597 LXN FRUCTOSAMINE TEST SYSTEM Lxn Corp. LCP Class II 1997-06-13
K970824 MDX 2000, DIGITAL ANALYZER Shotwell & Carr, Inc. JOY Class II 1997-05-30
K971748 TAS PT-NCTEST CONTROLS Cardiovascular Diagnostics, Inc. GGN Class II 1997-05-29
K964718 STA D-DI CALIBRATOR KIT American Bioproducts Co. DAP Class II 1997-05-23
K970189 FIF TM Panbio, Inc. KQJ Class II 1997-05-21
K970645 BC THROMBIN REAGENT Behring Diagnostics, Inc. GJA Class II 1997-05-19
K965232 CALTAG CAL-LYSE Caltag Laboratories, Inc. GKZ Class II 1997-05-14

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