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Hematology

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

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RecordFirmDate
EXACT ONE(TM) HEMATOLOGY ANALYZER (K900276)Exact Science, Inc.1990-04-16
ORTHO ABNORMAL PROTEIN C CONTROL PLASMA (K901233)Ortho Diagnostic Systems, Inc.1990-04-11
SIMULTEST IMK PLUS(TM) (K900078)Bd Becton Dickinson Vacutainer Systems Preanalytic1990-04-02
COULTER JT3 (K896873)Coulter Corp.1990-03-30
HEPARIN CONTROL PLASMA, FOR USE IN APTT (K900782)Medical Diagnostic Technologies, Inc.1990-03-27
RISTOCETIN (K900792)Medical Diagnostic Technologies, Inc.1990-03-27
PLATELIA TOXO IGG KIT (K894947)Kallestad Diag, A Div. of Erbamont, Inc.1990-03-23
TIP TOP(R) DISPENSER CAPS (K896670)Helena Laboratories1990-03-23
ORTHOKROME* FACTOR VIII (K900395)Ortho Diagnostic Systems, Inc.1990-03-15
PROTEIN S ANTIGEN ROCKET EID KIT, CAT. NO. 5359 (K896174)Helena Laboratories1990-03-15
ORTHOKROME* HEPARIN (K900396)Ortho Diagnostic Systems, Inc.1990-03-15
ORTHOKROME* ANTITHROMBIN (K900400)Ortho Diagnostic Systems, Inc.1990-03-15
ORTHOKROME* ANTIPLASMIN (K900397)Ortho Diagnostic Systems, Inc.1990-03-15
ORTHOKROME* PROTEIN C (K900398)Ortho Diagnostic Systems, Inc.1990-03-15
ORTHOKROME* PLASMINOGEN (K900399)Ortho Diagnostic Systems, Inc.1990-03-15
TECHNICON H*2(TM) SYSTEM (K900593)Technicon Instruments Corp.1990-03-14
MODIFIED COATRON II AND COATRON JR. (K900506)Astral Medical Systems1990-03-12
RET-CHECK (K900484)Streck Laboratories, Inc.1990-03-09
FACTOR V DEFICIENT PLASMA (K900406)Sigma Chemical Co.1990-03-06
FACTOR VII DEFICIENT PLASMA (K900407)Sigma Chemical Co.1990-03-06
FACTOR XII DEFICIENT PLASMA (K900412)Sigma Chemical Co.1990-03-06
FACTOR IX DEFICIENT PLASMA (K900409)Sigma Chemical Co.1990-03-06
FACTOR X DEFICIENT PLASMA (K900410)Sigma Chemical Co.1990-03-06
FACTOR II DEFICIENT PLASMA (K900906)Sigma Chemical Co.1990-03-06
FACTOR VIII DEFICIENT PLASMA (K900408)Sigma Chemical Co.1990-03-06
FACTOR XI DEFICIENT PLASMA (K900411)Sigma Chemical Co.1990-03-06
COLLEGE OF AMER PATH. REFER. PREP. FOR FIBRINOGEN (K900377)Baxter Healthcare Corp1990-03-06
COULTER CLONE T4 MONOCLONAL ANTIBODY (K893852)Coulter Immunology1990-03-02
COULTER CLONE T8 MONOCLONAL ANTIBODY (K893853)Coulter Immunology1990-03-02
COULTER CLONE(R) MY4 MONOCLONAL ANTIBODY (K894179)Coulter Immunology1990-02-12
AKS II (K895095)Amoco Technology Co.1990-02-09
PROTEIN C ANTIGEN ROCKET EID METHOD NO. 5357 (K897136)Helena Laboratories1990-02-05
TT AND HNTT BY HEMOCHRON (K900126)International Technidyne Corp.1990-02-05
MADIN-DARBY CANINE KIDNEY CULTURE CELLS (K896846)Baxter Healthcare Corp1990-02-01
REP GLYCO CONTROL NORMAL(3209) AND ABNORMAL(3210) (K900017)Helena Laboratories1990-01-29
ROCKET REFERENCE PLASMA, CAT NO. 5188 (K900019)Helena Laboratories1990-01-25
RAICHEM TM HEMOGLOBIN CALIBRATOR (K896921)Reagents Applications, Inc.1990-01-25
RAICHEM TM HEMOGLOBIN REAGENT (K896922)Reagents Applications, Inc.1990-01-25
APTT-EA REAGENT, AN ELLAGIC ACID ACTIVATED REAGENT (K900049)Medical Diagnostic Technologies, Inc.1990-01-25
RESUBMITTED FECATWIN SENSITIVE - FECA-EIA (K896474)Labsystems, Inc.1990-01-25
FACTOR II DEFICIENT PLASMA (K900133)Medical Diagnostic Technologies, Inc.1990-01-25
HEMOGLOBIN A2 MICRO COLUMN TEST (K896168)Bio-Rad1990-01-18
CBC-CAL(TM) PLUS HEMATOLOGY CALIBRATOR/MULTIPLE (K897060)R&D Systems, Inc.1990-01-02
CYTO-STAT/COULTER CLONE T4-RD1/T8-FITC MONO ANTI (K895917)Coulter Immunology1989-12-29
SIMULTEST IMK FOR FACS ANALYZER OR FACSCAN (K890349)Becton Dickinson Immunocytometry Systems1989-12-29
SQA (K894949)United Medical Systems, Inc.1989-12-29
CLP GLYCOSYLATED HEMOGLOBIN CONTROL-ER (K896334)Creative Laboratory Products, Inc.1989-12-11
THROMBOPLASTIN, FOR USE IN PROTHROMBIN TIME DETER. (K896625)Medical Diagnostic Technologies, Inc.1989-12-11
CLP GLYCOSYLATED HEMOGLOBIN CONTROL-NR (K896335)Creative Laboratory Products, Inc.1989-12-11
GLYCOTEST II GLYHB ASSAY KIT (K895661)Pierce Chemical Co.1989-12-07
ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) (K896545)Sigma Chemical Co.1989-12-01
SICKLE CELL SOLUBILITY TEST KIT (K895745)Simmler, Inc.1989-11-29
EPO-TRAC BY RADIOIMMUNOASSAY (RIA) (K893393)Incstar Corp.1989-11-21
ALKALINE PHOSPHATASE, LEUKOCYTE, KIT (K896092)Sigma Chemical Co.1989-11-09
PARA TECH FOR TECHNICON H-1 (K896154)Streck Laboratories, Inc.1989-11-09
FIBRINOGEN ASSAY KIT (K896052)Medical Diagnostic Technologies, Inc.1989-11-09
AVL MODEL 912 CO-OXYLITE (K895466)Avl Scientific Corp.1989-11-06
FDP COLLECTION TUBES (K896033)Medical Diagnostic Technologies, Inc.1989-10-27
MODIFIED HEMOGLOBIN REAGENT SET (K894951)Macomb Biotechnology, Inc.1989-10-24
THROMBELASTOGRAPH(R) (K895844)Haemoscope Corp.1989-10-24
GLYCABEN (K893453)Exocell, Inc.1989-10-23
CREATININE FOR MANUAL OR AUTOMATED APPLICATIONS (K894389)Catachem, Inc.1989-10-12
CLINIGEN ERYTHROPOIETIN HUMAN SERUM CONTROLS 1,2,3 (K894943)Amgen, Inc.1989-10-10
BIOTRACK HEMOGLOBIN TEST CARTRIDGE (K895101)Biotrack, Inc.1989-10-10
ARGOS (K895127)Abx, Inc.1989-10-10
ABNORMAL REFERENCE PLASMA-VIII (K895503)Medical Diagnostic Technologies, Inc.1989-10-06
APTT-P REAGENT, A PARTICLE ACTIVATED REAGENT (K895255)Medical Diagnostic Technologies, Inc.1989-10-06
ABNORMAL REFERENCE PLASMA-IX (K895504)Medical Diagnostic Technologies, Inc.1989-10-06
HEMATOLOGY CONTROL (K895373)Medical Specialties Intl., Inc.1989-10-06
ABNORMAL COAGULATION CONTROL PLASMA-2 (ACCP-2) (K895261)Medical Diagnostic Technologies, Inc.1989-10-06
ABNORMAL COAGULATION CONTROL PLASMA-1 (ACCP-1) (K895260)Medical Diagnostic Technologies, Inc.1989-10-06
NORMAL COAGULATION CONTROL PLASMA (NCCP) (K895262)Medical Diagnostic Technologies, Inc.1989-10-06
TRU-TRAX (K894851)Humagen, Inc.1989-09-29
SYSMEX R-1000 AUTOMATED RETICULOCYTE ANALYZER (K894539)Toa Medical Electronics USA, Inc.1989-09-26
COULTER POSITIVE CONTROL CELLS (K894651)Coulter Corp.1989-09-13
CLOTRAC CITRATED WHOLE BLOOD COAGULATION CONTROLS (K894359)Hemotec, Inc.1989-09-05
HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS. (K894317)Hemotec, Inc.1989-09-05
THROMBIN TIME REAGENT (K894467)Sigma Chemical Co.1989-09-05
HEPCON(R) CV WHOLE BLOOD COAGULATION CONTROLS (K894466)Hemotec, Inc.1989-09-05
SALMONELLA IFA* (K885114)Investigacion Farmaceutica S.A. DE C.V.1989-08-15
COULTER CLONE MO2 (K884605)Coulter Immunology1989-08-15
HGB-CAL SET/MULTIPLE (K893984)R&D Systems, Inc.1989-08-15
HGB-CONTROL SET/MULTIPLE (K893985)R&D Systems, Inc.1989-08-15
ACS HUMAN PLASMA COAGULATION CONTROL LEVEL III (K894425)Analytical Control Systems, Inc.1989-08-03
QBC MALARIA SYSTEM (K891276)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-08-03
ABBOTT IMX(TM) D-DIMER (K893961)Abbott Laboratories1989-08-03
CHARISE CHARLES REAGENT BLOOD STRIPS (K893894)Lee Import Domestic Consulting1989-07-27
ELECTRA 1000C AUTOMATIC COAGULATION TIMER (K894052)Medical Laboratory Automation Systems, Inc.1989-07-27
ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL III (K894338)Analytical Control Systems, Inc.1989-07-25
ACS HUMAN PLASMA COAGULATION CONTROL LEVEL II (K893970)Analytical Control Systems, Inc.1989-07-25
ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL II (K893971)Analytical Control Systems, Inc.1989-07-25
HEMATOLOGY CONTROL MIXTURES FOR QUALITY CONTROL (K893895)Intercare Diagnostics, Inc.1989-07-25
MODIFIED POLYCHROME IV STAIN (K894045)Devetec, Inc.1989-07-25
A.QC HCT LEVEL 1 AND 2 (K893562)Johnson & Johnson Professionals, Inc.1989-07-14
THROMBOSTIN IFA* (K885107)Investigacion Farmaceutica S.A. DE C.V.1989-06-23
FACTOR VIII DEFICIENT PLASMA (K893525)Medical Diagnostic Technologies, Inc.1989-06-23
LIFECELL RECOVERY CONTAINER (K893787)Baxter Healthcare Corp1989-06-23
ACS HUMAN PLASMA COAGULATION CONTROL LEVEL I (K893784)Analytical Control Systems, Inc.1989-06-23
FACTOR IX DEFICIENT PLASMA (K893524)Medical Diagnostic Technologies, Inc.1989-06-23
THE STAGO VIII DEFICIENT PLASMA KIT (K892859)American Bioproducts Co.1989-06-23
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