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Hematology

4,194 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
BAIR HUGGER BLOOD/FLUID WARMER (K973741)Augustine Medical, Inc.1998-04-30
SIGMA DIAGNOSTICS ACCUCLOT CONTROL I (K981248)Sigma Diagnostics, Inc.1998-04-29
SIGMA DIAGNOSTICS ACCUCLOT CONTROL III (K981255)Sigma Diagnostics, Inc.1998-04-29
SIGMA DIAGNOSTICS ACCUCLOT CONTROL II (K981254)Sigma Diagnostics, Inc.1998-04-29
THROMBOLYTIC ASSESSMENT SYSTEM LOW RANGE HEPARIN MANAGEMENT TEST CONTROLS (K981178)Cardiovascular Diagnostics, Inc.1998-04-27
ABBOTT CELL-DYN 3000 SERIES HEMATOLOGY SYSTEMS (K980614)Abbott Laboratories1998-04-24
IL TEST PROTEIN C (K980875)Instrumentation Laboratory CO1998-04-21
COAMATIC FACTOR VIII (K981038)Instrumentation Laboratory CO1998-04-16
AVOCET SYSTEM LIQUID CONTROL LEVEL 1 AND LEVEL 2 (K980982)Avocet Medical, Inc.1998-04-16
MDA D-DIMER (K974776)Organon Teknika Corp.1998-04-16
FETAL D TECTION KIT (K980314)Biopool Intl., Inc.1998-04-08
IL TEST ANTITHROMBIN (K980499)Instrumentation Laboratory CO1998-04-02
IL TEST HEPARIN (K980242)Instrumentation Laboratory CO1998-03-19
CO-STAT(TM) END TIDAL BREATH ANALYZER (K974805)Natus Medical, Inc.1998-03-11
MULTITEST CD3/CD8/CD45/CD4 (K974360)Becton Dickinson Immunocytometry Systems1998-03-11
VIDAS D-DIMER (DD) ASSAY (K973819)Biomerieux Vitek, Inc.1998-03-10
MDA SIMPLASTIN HTF (K974566)Organon Teknika Corp.1998-02-24
FACSCOMP SOFTWARE AND CALIBRITE BEADS FOR USE IN FLOW CYTOMETER INSTRUMENT SET (K973483)Becton Dickinson Immunocytometry Systems1998-02-17
COAGUCHEK SYSTEM, COAGUCHEK SYSTEM FOR PROTHROMBIN TIME SELF TESTING (K974569)Boehringer Mannheim Corp.1998-01-09
IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT (K974110)Beckman Instruments, Inc.1997-12-24
RANDOX BILIRUBIN (K973995)Randox Laboratories, Ltd.1997-12-08
TRI TEST REAGENT CD4 FIT C/CD8 PE/CD3 PERCP WITH TRUCOUNT ABSOLUTE COUNT TUBES (K971205)Becton Dickinson Immunocytometry Systems1997-12-01
TRITEST REAGENT CD3 FITC/CD16+CD56 PE/CD45 PERCP;WITH TRUCOUNT ABSOLUTE COUNT TUBES (K971110)Becton Dickinson Immunocytometry Systems1997-11-25
SYNCHRON SYSTEM HEMOGLOBIN ALC REAGENT (K973696)Beckman Instruments, Inc.1997-11-24
TRITEST REAGENT CD3 FITC/CD8 PE/CD45 PERCP;WITH TRUCOUNT ABSOLUTE COUNT TUBES (K970326)Becton Dickinson Immunocytometry Systems1997-11-21
TRITEST REAGENT CD3 FITC/CD4 PE/CD45 PERCP; TRUCOUNT ABSOLUTE COUNT TUBES (K965053)Becton Dickinson Immunocytometry Systems1997-11-21
HEMOCHRON CITRATE APTT (K972831)International Technidyne Corp.1997-11-20
DADE PFA-100 PLATELET FUNCTION ANALYZER/PFA COLLAGEN/EPINEPHRINE TEST CARTRIDGE/PFA COLLAGEN/ADP TEST CARTRIDGE/ (K970505)Dade Intl., Inc.1997-11-17
MICRO21 WITH WBC ESTIMATE (K973050)Triangle Biomedical Sciences, Inc.1997-11-07
IL TEST APTT-SP (K973306)Instrumentation Laboratory CO1997-11-04
IL TEST D-DIMER (K972696)Instrumentation Laboratory CO1997-11-04
ACCUCOLOR HIGH CALIBRATOR (A3089) (K973274)Sigma Diagnostics, Inc.1997-10-31
COULTER AC.T DIFF ANALYZER (K973634)Coulter Corp.1997-10-29
CRAFT DUO-VAC SUCTION UNIT, CRAFT SUCTION UNIT (K972867)Rocket Medical Plc1997-10-24
TRITEST CD3 FITC/CD19 PE/CD45 PERCP REAGENT WITH TRUCOUNT ABSOLUTE COUNT TUBES (K970742)Becton Dickinson Immunocytometry Systems1997-10-22
N-ASSAY TIA ANTITHROMBIN III TEST KIT (K972257)Crestat Diagnostics, Inc.1997-10-20
CS-400 COAGULATION ANALYZER SYSTEM (A1208) (K972260)Sigma Diagnostics, Inc.1997-10-20
HEMAPROMPT (K972763)Aerscher Diagnostics1997-10-20
N-ASSAY TIA PLASMINOGEN TEST KIT (K971985)Crestat Diagnostics, Inc.1997-10-20
SIGMA DIAGNOSTICS THROMBOMAX WITH CALCIUM (K972796)Sigma Diagnostics, Inc.1997-10-10
SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A) (K971858)Sigma Diagnostics, Inc.1997-10-09
REAADS PROTEIN C ANTIGEN TEST KIT (K972342)Reaads Medical Products, Inc.1997-10-06
B&D ACTIVATED CLOTTING TIME (ACT) TEST TUBES BD-C101 (DIATOMACEOUS EARTH) AND BD-K101 (KAOLIN) (K971935)B & D Corp.1997-10-01
FRESH CELLS WI-38 (K973212)Diagnostic Hybrids, Inc.1997-09-25
FRESH CELLS MV1LU (K973211)Diagnostic Hybrids, Inc.1997-09-25
A1C 2.2 PLUS - AUTOMATED GLYCOHEMOGLOBIN ANALYZER (K972265)Tosoh Medics, Inc.1997-09-25
FRESH CELLS NCI H292 (K973210)Diagnostic Hybrids, Inc.1997-09-25
UNIVERSAL REAGENT FACTOR XII (TWELVE) DEFICIENT PLASMA (K973143)Universal Reagents, Inc.1997-09-25
FRESH CELLS VERO (K973209)Diagnostic Hybrids, Inc.1997-09-25
FRESH CELLS HFF (K973214)Diagnostic Hybrids, Inc.1997-09-25
FRESH CELLS LLC-MK2 (K973213)Diagnostic Hybrids, Inc.1997-09-25
AUTOMATED MULTI-POINT BLOOD VOLUME ANALYZER (K964406)Daxor Corporation1997-09-25
QUICK-DRAW CAPILLARY WHOLE BLOOD COLLECTION SYSTEM (K972969)Innovative Medical Technologies, Inc.1997-09-22
RHMK II CELL CULTURE, AN EXPANDED PRIMARY RHESUS MONKEY KIDNEY CELL CULTURE (K971508)Bio-Whittaker, Inc., A Cambrex Co.1997-09-17
MICRO21 WITH CEREBROSPINAL FLUID (K971470)Triangle Biomedical Sciences, Inc.1997-09-16
ABBOTT CELL-DYN 3200 SYSTEM (K972354)Abbott Laboratories1997-09-16
OPUS D-DIMER (K972316)Behring Diagnostics, Inc.1997-09-09
EZCHEK/HBA BLOOD COLLECTION KIT (K971919)Flexsite Diagnostics, Inc.1997-09-05
FRESHCELLS (K972414)Diagnostic Hybrids, Inc.1997-08-29
CRYO CHECK INR VALIDATION SET (K971219)Precision Biologicals, Inc.1997-08-29
ADVIA 120 HEMATOLOGY SYSTEM, IN VITRO DIAGNOSTIC SYSTEM (K971998)Bayer Corp.1997-08-29
SYSMEX IMMATURE RETICULOCYTE FRACTION (IRF) PARAMETER (K971736)Sysmex Corp.1997-08-26
TRUCOUNT ABSOLUTE COUNT TUBES/COUNTING CONTROL BEADS (K970836)Becton Dickinson Immunocytometry Systems1997-08-26
CRYO CHECK APC RESISTANT PLASMA (K971222)Precision Biologicals, Inc.1997-08-19
ASSERACHROM TPA TEST KIT (K971519)American Bioproducts Co.1997-08-19
TRACCELL 2000 SLIDE MAPPING SYSTEM (K964689)Accumed Intl., Inc.1997-08-18
REAADS PROTEIN S ANTIGEN TEST KIT (K972482)Reaads Medical Products, Inc.1997-08-13
REAADS VON WILLEBRAND FACTOR ANTIGEN TEST KIT (K972005)Reaads Medical Products, Inc.1997-08-13
PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR V DEFICIENT PLASMA (THROMBOSDREEN BRAND) (100056) (K972627)Pacific Hemostasis1997-08-13
SPECTROLYSE HEPARIN (ANTI-IIA) (K972209)Medical Diagnostic Technologies, Inc.1997-08-12
ABBOTT CELL-DYN 4000 IMMATURE RETICULOCYTE FRACTION (IRF) (K971152)Abbott Laboratories1997-08-12
SIGMA DIAGNOSTICS ACCUCOLOR ANTITHROMBIN III (K972144)Sigma Diagnostics, Inc.1997-07-25
VON WILLEBRAND REAGENT (K972116)Behring Diagnostics, Inc.1997-07-25
ESR CONTROL-M HEMATOLOGY ERYTHROCYTE SEDIMENTATION (K972172)R&D Systems, Inc.1997-07-24
ESR CONTROL-HC HEMATOLOGY ERYTHROCYTE SEDIMENTATION (K972170)R&D Systems, Inc.1997-07-24
VACUTAINER BRAND SAFETY BLOOD COLLECTION ASSEMBLY(MULTIPLE) (K972404)Bd Becton Dickinson Vacutainer Systems Preanalytic1997-07-22
CRYO CHECK FACTOR V DEFICIENT PLASMA (K971223)Precision Biologicals, Inc.1997-07-22
CRYO CHECK FACTOR X DEFICIENT PLASMA (K971227)Precision Biologicals, Inc.1997-07-18
CRYO CHECK FACTOR IX DEFICIENT PLASMA (K971226)Precision Biologicals, Inc.1997-07-18
CRYO CHECK FACTOR VIII DEFICIENT PLASMA (K971225)Precision Biologicals, Inc.1997-07-17
CRYO CHECK FACTOR VII DEFICIENT PLASMA (K971224)Precision Biologicals, Inc.1997-07-17
ORTHO-MUNE OKT 4A (CD4) - MONOCLONAL ANTIBODY (MURINE) FITC CONJUGATE (K951459)Ortho Diagnostic Systems, Inc.1997-07-14
FACTOR DEFICIENT PLASMAS - FACTOR IX (9) (K972288)Universal Reagents, Inc.1997-07-14
FACTOR DEFICIENT PLASMAS - FACTOR XI (11) (K972286)Universal Reagents, Inc.1997-07-14
COULTER ACT TRON CELL CONTROL (K971469)Coulter Corp.1997-06-30
STA LIATEST CONTROL [N]+[P] KIT (K964716)American Bioproducts Co.1997-06-26
STA-LIATEST D-DI TEST KIT (K964728)American Bioproducts Co.1997-06-26
MOUSE ANTI-HUMAN CD45, LEUCOCYTE COMMON ANTIGEN (LCA)/FITC AND CD14, MONOCYTE/RPE (K964974)Dako Corp.1997-06-24
COAGULATION CONTROL PLASMA(ABNORMAL)LEVEL 0 (K971428)Pacific Hemostasis1997-06-17
DIASCREEN REAGENT STRIPS (K971976)Dia-Screen Corp.1997-06-17
LXN FRUCTOSAMINE TEST SYSTEM (K962597)Lxn Corp.1997-06-13
MDX 2000, DIGITAL ANALYZER (K970824)Shotwell & Carr, Inc.1997-05-30
TAS PT-NCTEST CONTROLS (K971748)Cardiovascular Diagnostics, Inc.1997-05-29
STA D-DI CALIBRATOR KIT (K964718)American Bioproducts Co.1997-05-23
FIF TM (K970189)Panbio, Inc.1997-05-21
BC THROMBIN REAGENT (K970645)Behring Diagnostics, Inc.1997-05-19
CALTAG CAL-LYSE (K965232)Caltag Laboratories, Inc.1997-05-14
BEHRING COAGULATION SYSTEM (K970431)Behring Diagnostics, Inc.1997-05-05
UNIVERSAL REAGENT FACTOR VII DEFICIENT PLASMA (K970607)Universal Reagents, Inc.1997-04-25
UNIVERSAL REAGENT FACTOR VIII DEFICIENT PLASMA (K970593)Universal Reagents, Inc.1997-04-25
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