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Hematology

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

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RecordFirmDate
ACTICHROME ATIII KIT (K893608)American Diagnostic Corp.1989-06-23
FACTOR VII DEFICIENT PLASMA (K893535)Medical Diagnostic Technologies, Inc.1989-06-23
PLATELET AGGREGATION PROFILER MODEL PAP-4C (K893650)Bio/Data Corp.1989-06-23
FACTOR X DEFICIENT PLASMA (K893523)Medical Diagnostic Technologies, Inc.1989-06-23
FACTOR XII DEFICIENT PLASMA (K893534)Medical Diagnostic Technologies, Inc.1989-06-23
FACTOR XI DEFICIENT PLASMA (K893536)Medical Diagnostic Technologies, Inc.1989-06-23
ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL I (K893783)Analytical Control Systems, Inc.1989-06-23
FACTOR V DEFICIENT PLASMA (K893533)Medical Diagnostic Technologies, Inc.1989-06-23
APTT BY HEMOCHRON(R) (K892209)Intensive Technology, Inc.1989-06-22
PROTHROMBIN TIME (PT) BY HEMOCHRON (K893378)International Technidyne Corp.1989-06-22
REP GLYCO-8 KIT, #3208/REP GLYCO-16 KIT, #3207 (K893224)Helena Laboratories1989-06-20
QBC III CENTRIFUGAL HEMATOLOGY SYSTEM (K893423)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-06-20
PRIMUS MODEL CLC 330 (K891235)Primus, Inc.1989-06-16
DANAM VECTOR-8+ (K892205)Danam Electronics1989-06-13
AMICON VITAFIBER FLO-PATH BIORECT/VLS CELL CULT SY (K892645)Amicon, Inc.1989-06-13
IRISTAIN FORMULA 2, PARTS 1 AND 2 (K893530)Intl. Remote Imaging Systems1989-06-13
INSTANT EOSIN-AQUEOUS (K893663)Shandon, Inc.1989-06-13
HELENA THROMBOPLASTIN REAGENT (K892050)Helena Laboratories1989-06-07
LEUCOPREP CELL SEPARATION TUBE (K891407)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-05-26
SR30/SR50/SR60 AUTO SEDIMENT RATE SYSTEM, MODIFIED (K892522)Gespac, Inc.1989-05-24
SDI PREPAX COUNTAPETTE KIT (K892658)Scientific Distributors, Inc.1989-05-24
COAG-1 APTT TEST CARD (K891015)Cardiovascular Diagnostic Services1989-05-22
AMNIO-GROW TM (K892938)Inovar Biologicals, Inc.1989-05-22
FETAL HEMOGLOBIN (K892241)Sure-Tech Diagnostic Associates, Inc.1989-05-17
PH BLOOD GAS CONTROL PRODUCTS (K884266)Alko Diagnostic Corp.1989-05-16
THROMBOSCREEN APTT REAGENT (K891337)Pacific Hemostasis1989-04-21
BERICHROM PROTEIN C KIT (K890634)Behring Diagnostics, Inc.1989-04-21
EDL ONE-STAGE PROTHROMBIN TIME REAGENT (K891370)Elite Diagnostic , Ltd.1989-04-21
BERICHROM ALPHA-2-ANTIPLASMIN (K884797)Behring Diagnostics, Inc.1989-04-21
ENZYGNOST PLATELET FACTOR 4 (PF4) KIT (K890633)Behring Diagnostics, Inc.1989-04-21
EDL GLOBAL ACTIVATED PARTIAL THROMBOPLASTIN TIME (K890859)Elite Diagnostic , Ltd.1989-04-21
HEMAWIPE SYSTEM, THE CIVILIZED TEST (K884206)Labeltape Meditect, Inc.1989-04-18
CELL-DYN 3000 MULTI-PARAMETER HEMATOLOGY ANALYER (K890491)Abbott Diagnostics1989-04-18
QBC(R) CENTRIFUGAL HEMATOLOGY CONTR/MULTI MODIFIED (K891907)R&D Systems, Inc.1989-04-11
DADE THROMBOPLASTIN IS (K891169)Baxter Healthcare Corp1989-04-10
EDL NORMAL COAGULATION CONTROL (K891179)Elite Diagnostic , Ltd.1989-04-10
EDL ABNORMAL COAGULATION CONTROL (K891175)Elite Diagnostic , Ltd.1989-04-10
SIGMA PROCEDURE NO. 465 FOR DETER. OF FRUCTOSAMINE (K884184)Sigma Diagnostics, Inc.1989-03-28
ABBOTT TESTPACK(TM) D-DIMER (K890422)Abbott Laboratories1989-03-27
ATS DOBELL & O'CONNOR'S IODINE (K890861)Alpha-Tec Systems, Inc.1989-03-23
NE-CHECK (K890767)Streck Laboratories, Inc.1989-03-23
HEMATASTAT H-70 (K890849)Separation Technology, Inc.1989-03-21
EDL ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT (K890619)Elite Diagnostic , Ltd.1989-03-15
ACTICLOT C KIT (K884941)American Diagnostic Corp.1989-03-13
RELLPLATE C KIT, RELLPLATE C BULK PLATES (K884940)American Diagnostic Corp.1989-03-13
AGEN DIMERTEST EIA (K890189)Agen Biomedical , Ltd.1989-03-03
DADE(R) PLASMINOGEN CHROMOGENIC ASSAY (K890409)Baxter Healthcare Corp1989-02-27
CBC-TECH (TM) HEMATOLOGY CONTROL/MULTIPLE (K890749)R&D Systems, Inc.1989-02-27
CLINISTAT HEMOGLOBIN REAGENT TEST (K885227)Heraeus Kulzer, Inc.1989-02-24
ENDOTHELIAL GROWTH MEDIUM (EGM) (K890701)Clonetics Corp.1989-02-24
ATS LUGOL'S IODINE SOLUTION (K890020)Alpha-Tec Systems, Inc.1989-02-24
WRIGHT-GLEMSA STAIN (K890673)Sigma Diagnostics, Inc.1989-02-24
MELANOCYTE GROWTH MEDIUM (MGM) (K890700)Clonetics Corp.1989-02-24
ACCUSTAIN(TM) - AUTOMATED WRIGHT GIEMSA STAIN SET (K890674)Sigma Diagnostics, Inc.1989-02-24
BIOTRACK APTT REAGENT CARTRIDGE (K890052)Biotrack, Inc.1989-02-24
BIOTRACK APTT CONTROLS (K890051)Biotrack, Inc.1989-02-23
COULTER FLOW RETICULOCYTE REAGENT (K885332)Coulter Electronics, Inc.1989-02-22
HEMA(PRO)TEC(TION) (K885324)Medical Products Search, Inc.1989-02-17
COULTER 5P CONTROL (K885028)Coulter Electronics, Inc.1989-02-16
CTS-3060 AUTOMATED SEMEN ANALYZER (K881765)Motion Analysis Corp.1989-02-15
MULTIWELL CULTURE PLATE INSERTS (K890542)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-02-14
ABC, ABC-1X, ABC(TM) (K890482)Cell Ent., Inc.1989-02-10
SR30/SR50/SR60 AUTOMATED SEDIMENTATION RATE (K890503)Gespac, Inc.1989-02-10
CAPILLARY TUBE, BLOOD COLLECTION (K885138)Coeur Laboratories, Inc.1989-02-07
MODIFIED D-DI-TEST KIT (K890399)American Bioproducts Co.1989-02-07
COULTER CLONE T3 MONOCLONAL ANTIBODY (K883710)Coulter Immunology1989-02-03
ELECTRA 900C AUTOMATIC COAGULATION TIMER (K884863)Medical Laboratory Automation Systems, Inc.1989-02-03
COULTER CLONE B4 MONOCLONAL ANTIBODY (K884020)Coulter Immunology1989-02-03
KOAGULAB* 32-S COAGULATION SYSTEM (K885035)Ortho Diagnostic Systems, Inc.1989-02-03
COULTER CLONE T1 MONOCLONAL ANTIBODY (K883753)Coulter Immunology1989-02-03
DADE PROTEIN C CHROMOGENIC ASSAY (K884881)Baxter Healthcare Corp1989-02-02
DADE(R) PROTOTROL SYNTHETIC SUBSTRATE ASSAY CONTRO (K884901)Baxter Healthcare Corp1989-02-02
COAGULATION CONTROL PLASMA (NORMAL & ABNORMAL) (K884854)Precision Biologicals, Inc.1989-01-30
THROMBOPLASTIN (K884855)Precision Biologicals, Inc.1989-01-30
APTT REAGENT (K884856)Precision Biologicals, Inc.1989-01-30
EASY-TEST PARTIAL THROMBOPLASTIN TIME PTT #16629 (K884702)Em Diagnostic Systems, Inc.1989-01-27
NOVA CELLTRAK 11 AUTO. HEMA. ANALYZER, CALIBRATORS (K884618)Nova Biomedical Corp.1989-01-24
PALL HEPCHEK (TM) HEPARIN ABSORPTION FILTER (K884534)Pall Biomedical Products Co.1989-01-24
ATS TB RAPID STAIN SET PRODUCT #034-45 (K890148)Alpha-Tec Systems, Inc.1989-01-24
HEPCON/SYSTEM B-10 HEPARIN ASSAY/SCREEN/CARTRIDGES (K884590)Hemotec, Inc.1989-01-10
DADE FACTOR IX CHROMOGENIC ASSAY (K884551)Baxter Healthcare Corp1988-12-30
DADE FACTOR VIII CHROMOGENIC ASSAY (K884544)Baxter Healthcare Corp1988-12-30
COAG-A-MATE XC/XC PLUS VERSION D.00 SOFTWARE (K885076)Organon Teknika Corp.1988-12-30
FIBRI-PREST/THROMBIN-PREST CONTROLS (K884385)American Bioproducts Co.1988-12-28
THROMBIN-PREST REAGENT KIT (K884384)American Bioproducts Co.1988-12-28
COULTER STKS (K885093)Coulter Electronics, Inc.1988-12-28
KD ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT (K884485)King Diagnostics, Inc.1988-12-28
FACSMATE SAMPLE HANDLING DEVICE (K885132)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-12-28
CELL SCRAPER (K885121)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-12-28
KVM BLOOD CELL COUNTER (K884471)Kvm Instruments, Inc.1988-12-27
CYTO-STAT/COULTER CLONE T11-RD1/B1-FITC MONO. ANTI (K884346)Coulter Immunology1988-12-27
LABILE LYSING REAGENT (K884315)Helena Laboratories1988-12-27
TURBOX ANTITHROMBIN III (K884144)Unipath , Ltd.1988-12-20
TURBOX FIBRINOGEN (K884179)Unipath , Ltd.1988-12-20
ERYTHROPOIETIN ENZYME IMMUNOASSAY (K882686)Amgen, Inc.1988-12-20
COATEST PROTEIN C (K884058)Kabivitrum, Inc.1988-12-13
SYSMEX NE-8000 (K883997)Toa Medical Electronics USA, Inc.1988-12-05
HEMAT 12 (K884006)Texas Intl. Laboratories, Inc.1988-12-05
MODIFIED LOW-TEMP. FREEZER MODEL HLT-80LS-85 (K884436)Harris Mfg. Co.1988-12-02
SAFE-TEC CAPILLARY BLOOD COLLECTION TUBE (K884623)Safe-Tec Clinical Products, Inc.1988-12-01
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