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Hematology

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

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RecordFirmDate
COAGUCHEK PST SYSTEM (K962571)Boehringer Mannheim Corp.1997-04-22
HYDRAGEL 15 HB A1C KIT (K963844)Morax1997-04-22
HUMAN PROTEIN S RID TEST KIT (K951640)The Binding Site, Ltd.1997-04-21
CBC-4K HEMATOLOGY CONTROL (K970331)R&D Systems, Inc.1997-04-16
N-ASSAY TIA FIBRINOGEN TEST KIT (K965113)Crestat Diagnostics, Inc.1997-04-16
SYSMEX CA-1000/SYSMEX CA-5000 (K964946)Sysmex Corp.1997-03-18
THROMBONOSTIKA F1.2 (K964934)Organon Teknika Corp.1997-03-18
MDA HEPARIN ANTI-X ASSAY (K965076)Organon Teknika Corp.1997-03-18
SYSMEX SE/RAM-1 (K964375)Sysmex Corp.1997-03-13
PROTIME MICROCOAGULATION SYSTEM (K961835)International Technidyne Corp.1997-03-12
SPECKTIN-LA TEST SET (K961892)Analytical Control Systems, Inc.1997-03-07
ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE MONOCLONAL ANTIBODY (MURINE) (K951632)Ortho Diagnostic Systems, Inc.1997-03-06
COULTER AC.T SERIES ANALYZER (K964988)Coulter Corp.1997-03-06
ACTALYKE ACTIVATED CLOTTING TIME TEST SYSTEM/CLOTTING TIME TUBES/WHOLE BLOOD QC KIT/ACTALYKE ELECTRONIC CLOTTING TUBE (K964609)Array Medical, Inc.1997-03-06
SPIRIT HEMATOLOGY SYSTEM MODEL LE, CP, & AX (K960072)Biochem Immunosystems (U.S.), Inc.1997-03-06
LYPHOCHEK COAGULATION CONTROL (K964963)Bio-Rad1997-02-20
HEMATACHEK (K964452)Richmond Diagnostics, Inc.1997-02-20
SYSMEX CA-6000 (K964139)Dade Intl., Inc.1997-02-06
MINK LUNG CELL CULTURE (K965047)Neogenex1997-02-04
COAG-A-MATE MTX (K962857)Organon Teknika Corp.1997-01-22
ORTHO-MUNE OKB (CD19)- MONOCLONAL ANTIBODY (MURINE) PHYCOERYTHRINE CONJUGATE (K964754)Ortho Diagnostic Systems, Inc.1997-01-22
TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS AND CYTO-STAT TERTRACHROME CD45-FITC/CD4-RDI/CD8-ECD/CD3-PC5 (K963263)Coulter Corp.1997-01-22
CD3 FITC/CD19 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION (K964856)Caltag Laboratories, Inc.1997-01-17
CYTO-STAT TRICHROME CD45-FITC/CD8-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT IWTH ISOTYPIC CONTROL (K962305)Coulter Corp.1997-01-06
CYTO-STAT TRICHROME CD45-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANITBODY REAGENT W/ISOTYPIC CONTROL (K962768)Coulter Corp.1997-01-06
COATEST APC (TM) RESISTANCE V/COATEST APC (TM) RESISTANCE V S (K963111)Chromogenix AB1996-12-23
CYTO-STAT TRICHROME CD8-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME MSIGGI-FITC/MSIGGI-RD1 (K964618)Coulter Corp.1996-12-23
UNIVERSAL REAGENT FACTOR X DEFICIENT PLASMA (K964459)Universal Reagents, Inc.1996-12-18
THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS (K962864)Alko Diagnostic Corp.1996-12-18
UNIVERSAL REAGENT FACTOR V DEFICIENT PLASMA (K964270)Universal Reagents, Inc.1996-12-18
PROC APC ASSAY, PROC CONTROL PLASMA (K962968)Behring Diagnostics, Inc.1996-12-13
MULTISET SOFTWARE FOR AUTOMATED FLOW CYTOMETRIC DATA ANALYSIS (K963963)Becton Dickinson Immunocytometry Systems1996-12-12
THOR HENOSTATSIS ANALYZER CAT. NO. 1450, 1451 (K961908)Helena Laboratories1996-12-10
QUANTITATIVE FIBRINOGEN ASSAY (K963902)Ortho Diagnostic Systems, Inc.1996-11-29
CD 19 R-PE, CD19 TRI-COLOR MONOCLONAL ANTIBODY (K963954)Caltag Laboratories, Inc.1996-11-25
CHROMOLIZE PAI-1 KIT (K963106)Medical Diagnostic Technologies, Inc.1996-11-18
SHIELD VON WILLEBRAND FACTOR ACTIVITY (ELISA) ASSAY (K962825)Shield Diagnostics, Ltd.1996-11-15
HEMOCUE HEMOTROL (K964052)Direct Solutions1996-11-06
FLEXSURE OBT (K961062)Smithkline Diagnostics, Inc.1996-11-06
VEGA HEMATOLOGY ANALYZER (K962633)Abx, Inc.1996-11-04
COULTER GEN-S SYSTEM (K962988)Coulter Corp.1996-10-30
SYSMEX UF-100 (K961054)Sysmex Corp.1996-10-28
STA - LIATEST VWF TEST KIT (K962675)American Bioproducts Co.1996-10-25
CHRONO-LOG WHOLE BLOOD AGGREGOMETER (WBA) 591/592 (K962426)Chrono-Log Corp.1996-10-22
TPP (K962176)Panbio, Inc.1996-10-18
ABBOTT CELL-DYN 4000 SYSTEM (K961439)Abbott Diagnostics1996-10-18
HEMOCUE HEMOLIN (K963908)Direct Solutions1996-10-16
FACTOR DEFICIENT PLASMA (K961929)Universal Reagents, Inc.1996-10-10
CELL DYN 3500 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER (MODIFICATION) (K955715)Abbott Laboratories1996-10-08
ROCHE UNIMATE FRUCTOSAMINE REAGENT (K961674)Roche Diagnostic Systems, Inc.1996-09-27
HEMOCUE B-HEMOGLOBIN SYSTEM (K961312)Hemocue, Inc.1996-09-24
STA-VWF CALIBRATOR KIT (K962671)American Bioproducts Co.1996-09-13
KC 40 MICRO COAGULATION ANALYZER SYSTEM (K3632) (K960875)Sigma Diagnostics, Inc.1996-09-10
ELECTRA 1800C AUTOMATIC COAGULATION ANALYZER (K962664)Medical Laboratory Automation Systems, Inc.1996-09-10
ACL 6000 SYSTEM (ACL 6000) (K961991)Instrumentation Laboratory CO1996-09-04
RETICULOCYTE METHOD (K954607)Bayer Corp.1996-08-30
FRESHFROZENCELLS (K962311)Diagnostic Hybrids, Inc.1996-08-29
FRESHFROZEN CELLS, HEP-2 (K962782)Diagnostic Hybrids, Inc.1996-08-29
FRESHCELLS, HEP-2 (K962780)Diagnostic Hybrids, Inc.1996-08-29
FRESH CELLS MULTI-WELL & SHELL VIAL CULTURES (K962306)Diagnostic Hybrids, Inc.1996-08-29
RETICULOCYTE METHOD, RBC INDICES (K954594)Bayer Corp.1996-08-23
SICKLE-2000 (K955719)Medicus Technologies, Inc.1996-08-14
SPECTROLYSE ANTITHROMBIN III (ANTI-XA) (K960871)Medical Diagnostic Technologies, Inc.1996-08-14
THROMBOLYTIC ASSESSMENT SYSTEM PROTHROMBIN TIME TEST CONTROLS (K961814)Cardiovascular Diagnostics, Inc.1996-08-13
HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACT (K960749)International Technidyne Corp.1996-08-12
CHROMOLIZE TPA ASSAY KIT (K962489)Medical Diagnostic Technologies, Inc.1996-07-31
N/T PROTEIN CONTROL PY (K962407)Behring Diagnostics, Inc.1996-07-29
CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4 (K961807)Ciba Corning Diagnostics Corp.1996-07-26
STA - VWF CONTROL [N]+[P] KIT (K962674)American Bioproducts Co.1996-07-23
COULTER STKS ANALYZER WITH CD4 & CD8 LYMPHOCYTE ANALYSIS (K961278)Coulter Corp.1996-07-22
MOUSE ANTI-HUMAN CD3, T-CELL, FITC AND CD4, T-CELL, (HELPER/INDUCER) RPE (K961701)Dako Corp.1996-07-16
R&D RETIC-PG HEMATOLOGY CONTROL (K961673)R&D Systems, Inc.1996-07-15
STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER (K961579)American Bioproducts Co.1996-07-10
MCCOY CELL CULTURES (K955608)Vai Diagnostics, Inc.1996-07-08
SPUNCRIT (MODEL DRC-40) (K961803)Micro Diagnostics Corp.1996-07-05
R & D SYSTEMS' WHOLE BLOOD FLOW CONTROL, (R & D - WBFC) (K961610)R&D Systems, Inc.1996-07-01
SAS SICKLE CELL TEST (K960947)Sa Scientific, Inc.1996-07-01
STAT PROFILE ULTRA L ANALYZER QUALITY CONTROL MATERIALS (K961938)Nova Biomedical Corp.1996-06-28
THERMACYL BLOOD/FLUID WARMER (K953741)Baxter Healthcare Corp1996-06-26
PLATELET FUNCTION TEST ASSAY CARTRIDGES FOR THE HEPCON HMS (K954202)Medtronic Hemotec, Inc.1996-06-20
MOUSE ANTI-HUMAN CD3, T-CELL/FITC & CD19, B-CELL/RPE (K960531)Dako Corp.1996-06-14
MOUSE ANTI-HUMAN CD2, T-CELL/FITC AND MOUSE ANTI-HUMAN CD19, B-CELL/RPE (K961435)Dako Corp.1996-06-14
HEMOGLOBIN ALC (HBA1C) & TOTAL ASSAYS FOR THE TECHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS (K955087)Bayer Corp.1996-06-13
FACSCOMP SOFTWARE & CALIBRITE 3 COLOR BEADS KIT/CALIBRITE PERCP BEADS (K961623)Becton Dickinson Monoclonal Center1996-06-07
MEDICOUNT DEKA HEMATOLOGY ANALYZER (K942525)Cea America Corp.1996-06-05
TINTELIZE PAI-1 KIT (K960438)Medical Diagnostic Technologies, Inc.1996-06-05
TAS A PTT TEST CONTROLS (K961189)Cardiovascular Diagnostics, Inc.1996-06-05
H292 CELL CULTURE (K960909)Neogenex1996-05-30
TAS HMT CONTROLS (K960234)Cardiovascular Diagnostics, Inc.1996-05-30
BEHRING COAGULATION TIMER (K955278)Behring Diagnostics, Inc.1996-05-30
ERYTHROPOIETIN IMMUNOASSAY KIT (K952559)Nichols Institute1996-05-29
CD-CHEX + RBC (K960894)Streck Laboratories, Inc.1996-05-24
LA POSITIVE CONTROL PLASMA (K961370)Medical Diagnostic Technologies, Inc.1996-05-24
NCI-H292 CELL CULTURE (K951461)Viromed Laboratories, Inc.1996-05-22
MICRO21 WITH ANA (K960774)Triangle Biomedical Sciences, Inc.1996-05-22
LLC-MK2 (MONKEY KIDNEY, MACACA MULATA) CELL CULTURE (K951440)Viromed Laboratories, Inc.1996-05-22
CELL DYN 3000 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER (MODIFICATION) (K955673)Abbott Laboratories1996-05-20
MICRO21 WITH RETIC (K960776)Triangle Biomedical Sciences, Inc.1996-05-17
QBC ACCUTUBE(423406)/QBC AUTOREAD(424571) (K960827)Becton Dickinson Diagnostic Instrument Systems1996-05-17
MOUSE ANTI-HUMAN CD4, T-CELL, HELPER/INDUCER/FITC & CD8, T-CELL, SUPPRESSOR/CYTOTOXIC/RPE (K960887)Dako Corp.1996-05-17
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