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Hematology

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

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RecordFirmDate
GENESIS 1, AUTOMATED CELL COUNTER, MODIFICATION (K925909)Alicia Diagnostics, Inc.1994-10-27
MONOJECT SAMPLETTE SEPARATOR TUBE (K941291)Sherwood Medical Co.1994-10-27
HEMOCHRON VERIGY SYSTEM/FACTOR VI QUALIFY SYSTEM (K940957)International Technidyne Corp.1994-10-18
AGGRO/LINK VW COFACTOR SOFTWARE (K940792)Chrono-Log Corp.1994-10-13
TINA-QUANT HEMOGLOBIN A1C (K934070)Boehringer Mannheim Corp.1994-10-11
SPECIALTY ASSAYED CONTROL-1 (K941737)Helena Laboratories1994-10-07
CBC-LINE HEMATOLOGY LINEARITY CONTROL (K942822)R&D Systems, Inc.1994-10-07
AUTOCOMP(TM) SOFTWARE AND CALIBRITE(TM) BEADS (K925274)Becton Dickinson Immunocytometry Systems1994-09-30
AURATEK FDP (K943787)Organon Teknika Corp.1994-09-20
MEDTRONIC HEMOTEC ACT II AUTOMATED COAGULATION TIMER (K940426)Medtronic Hemotec, Inc.1994-09-20
DVVTEST AND DVVCONFIRM LUPUS ANTICOAGULANT NORMAL AND ABNORMAL CONTROL PLASMA (K935254)American Diagnostica, Inc.1994-09-19
PRIMUS RAPID GEL 100 GLYCATED HEMOGLOBIN ASSAY (K942009)Primus Corp.1994-09-14
SPECIALTY ASSAYED REFERENCE PLASMA (S.A.R.P.) (K941860)Helena Laboratories1994-09-14
FASCOUNT SYSTME (K933486)Becton Dickinson Immunocytometry Systems1994-09-09
LIQUID FIBRINOGEN FDP CONTROL LEVEL 1 & 2 (K934741)Clinical Controls, Inc.1994-09-08
SEMEN ANALYSIS KIT (K915229)Humagen Fertility Diagnostics, Inc.1994-08-30
ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KIT (K941001)Diagnostic Specialties1994-08-30
FRESH CELLS MULTI-WELL PLATE CULTURES AND SHELL VIAL CULTURE (K936271)Diagnostic Hybrids, Inc.1994-08-26
QUANTIKINE IVD ERYTHROPOIETIN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) (K936016)R&D Systems, Inc.1994-07-19
AMES DCA 2000 HEMOGLOBIN ALC CONTROLS (K940971)Heraeus Kulzer, Inc.1994-07-19
ACT CONTROL SET (K940840)Sigma Diagnostics, Inc.1994-07-19
CATALOG NO. J-ACT+ & QC-ACT+ (K941007)International Technidyne Corp.1994-06-30
LIQUICHEK HEMATOLOGY-16 CONTROL, LOW, NORMAL AND HIGH (K942209)Bio-Rad1994-06-16
FRESH FROZEN CELLS (K940502)Diagnostic Hybrids, Inc.1994-06-16
CD-CHEX CD4 LOW (K931825)Streck Laboratories, Inc.1994-06-06
MICROCOAGULATION PROTHROMBIN TIME TEST (K940432)International Technidyne Corp.1994-05-18
ACCUCOLOR(TM) ANTITHROMBIN III CHROMOGENIC ASSAY (K935308)Sigma Diagnostics, Inc.1994-05-17
JR. MICROCOAGULATION SYSTEM (K940401)International Technidyne Corp.1994-05-11
HEMOLAB HEPARICHROM ASSAY (K934274)Biomerieux Vitek, Inc.1994-05-06
ANTITHROMBIN III CHROMOGENIC ASSAY (K936196)Baxter Diagnostics, Inc.1994-05-04
COATEST(R) ANTITHROMBIN III, MODIFICATION (K931420)Kabi Pharmacia Hepar, Inc.1994-05-02
SYSMEX SE-9000 AUTOMATED HEMATOLOGY ANALYZER (K936023)Toa Medical Electronics USA, Inc.1994-05-02
CD8 CYTOSPHERES KIT (K923951)Coulter Electronics, Inc.1994-04-25
BIOMERIEUX HEMOLAB THROMBICALCI-TEST (K925493)Biomerieux Vitek, Inc.1994-04-21
FIBRINOSTIKA(R) FGDP MICROELISA SYSTEM (K924892)Organon Teknika Corp.1994-04-21
QUANTIKINE(TM) ERYTHROPOIETIN HUMAN SERUM CONTROLS (K931756)R&D Systems, Inc.1994-04-21
HELENA THROMBOPLASTIN-MI REAGENT (K940310)Helena Laboratories1994-04-20
BERICHROM ANTITHROMBIN III (A) (K933125)Behring Diagnostics, Inc.1994-04-19
MULTIFIBREN U (K934326)Behring Diagnostics, Inc.1994-04-19
PARA 5 DIFF (K935196)Streck Laboratories, Inc.1994-04-05
RADIAS MONOCLONAL HBA 1C ASSAY (K935613)Bio-Rad1994-04-05
HEP-2 CULTURE CELL (K933927)Neogenex1994-03-31
HBM HEMOGLOBINOMETER (K933836)Artel, Inc.1994-03-31
THE YELLOW IRIS URINALYSIS WORKSTATION WITH IRISCOPE BODY FLUID ANALYSIS CAPABILITY (K934539)Intl. Remote Imaging Systems1994-03-30
KAPTON PEEL POUCH (K933228)American Fluoroseal Corp.1994-03-30
ASSESS(TM) LOW ABNORMAL CONTROL (K931117)Instrumentation Laboratory CO1994-03-30
ASSESS(TM) HIGH ABNORMAL CONTROL (K931118)Instrumentation Laboratory CO1994-03-30
A549 CULTURE CELL (K933923)Neogenex1994-03-29
MCCOY CULTURE CELL (K933924)Neogenex1994-03-29
MRC-5 CULTURE CELL (K933925)Neogenex1994-03-29
LLCMK2 CULTURE CELLS (K933926)Neogenex1994-03-29
CBC-COBAS 5 HEMATOLOGY CONTROL/MULTIPLE (K940089)R&D Systems, Inc.1994-03-22
GLYCATED HEMOGLOBIN CALIBRATORS (K936204)Primus Corp.1994-03-22
COAGULATION A.R.P. (K933277)Helena Laboratories1994-03-22
BIOMERIEUX UNIPLASMATROL NORMAL & ABNORMAL (K930267)Biomerieux Vitek, Inc.1994-03-22
GLYCATED HEMOGLOBIN CONTROLS (K940143)Primus Corp.1994-03-15
FACTOR VIII DEFICIENT PLASMA (K935057)Sigma Diagnostics, Inc.1994-03-15
ERYTHROPOIETIN IMMUNOASSAY KIT (K932650)Nichols Institute1994-03-11
COULTER MULTI Q PREP (K935953)Coulter Corp.1994-03-11
SE-CHECK (K940181)Streck Laboratories, Inc.1994-03-09
FACTOR VII DEFICIENT PLASMA (K935056)Sigma Diagnostics, Inc.1994-03-07
FACTOR (K935058)Sigma Diagnostics, Inc.1994-03-07
FACTOR X DEFICIENT PLASMA (K935054)Sigma Diagnostics, Inc.1994-03-07
STAGO FACTOR II-DEFICIENT PLASMA (K934606)American Bioproducts Co.1994-03-01
STAGO FACTOR V-DEFICIENT PLASMA (K934605)American Bioproducts Co.1994-03-01
TINTELIZER(R) TPA (K934314)Biopool AB1994-02-23
CONTROL PLASMA U (K924402)Behring Diagnostics, Inc.1994-02-22
PATHOPLASMA(R) I & II (PATH CITRATED HUMAN PLASMA) (K924401)Behring Diagnostics, Inc.1994-02-22
CONTROL PLASMA N (K924403)Behring Diagnostics, Inc.1994-02-22
IL TEST HEPARIN (XA), PN 84699-15 (K935212)Instrumentation Laboratory CO1994-02-07
FAST'N'FLAMMATORY KIT (K931241)Techlab, Inc.1994-02-03
RHESUS MONKEY KIDNEY CELLS (LLC-MK2) (K936172)Advanced Clinical Diagnostics1994-02-03
RHESUS MONKEY KIDNEY CELLS (K936169)Advanced Clinical Diagnostics1994-02-03
TRANSFORMED PRIMARY HUMAN EMBRYONAL KIDNEY (K936171)Advanced Clinical Diagnostics1994-02-03
HELA-229/HELA CELLS (K934973)Advanced Clinical Diagnostics1994-01-28
RABBIT KIDNEY CELLS - R.K.C. (K934934)Advanced Clinical Diagnostics1994-01-28
TOA MEDICAL ELECTRONICS CA-5000 (K933886)Toa Medical Electronics USA, Inc.1994-01-27
HEMOCARD, HEMOGLOBIN C ASSAY (K923153)Isolab, Inc.1994-01-27
MDA PROTEIN ASSAY (K925617)Organon Teknika Corp.1994-01-27
CENTRIFIQ BLOOD CONTROL (K935343)Hematronix, Inc.1994-01-27
SPECTROLYSE HEPARIN KIT (K923499)Biopool AB1994-01-27
PRIMARY AFRICAN GREEN MONKEY KIDNEY CELLS (K935766)Advanced Clinical Diagnostics1994-01-24
RHABDOMYOSARCOMA CELLS (K935337)Advanced Clinical Diagnostics1994-01-03
HELA HELA EPITHELOID CARCINOMA (K935339)Advanced Clinical Diagnostics1994-01-03
HUMAN LUNG DIPLOID CELLS-MRC-5 (K934244)Advanced Clinical Diagnostics1994-01-03
HUMAN FORESKIN FIBROBLAST CELLS-H.F.F. (K934245)Advanced Clinical Diagnostics1994-01-03
KIDNEY AFRICIAN GREEN MONKEY CELLS-VERO (K934240)Advanced Clinical Diagnostics1994-01-03
LUNG DIPLOID HUMAN CELLS-WI-38 (K934246)Advanced Clinical Diagnostics1994-01-03
LUNG CACINOMA, HUMAN CELLS (K935338)Advanced Clinical Diagnostics1994-01-03
BUFFALO GREEN MONKEY KIDNEY CELLS-B.G.M.K. (K934242)Advanced Clinical Diagnostics1994-01-03
KIDNEY AFRICAN GREEN MONKEY CELLS-CV-1 (K934239)Advanced Clinical Diagnostics1994-01-03
HUMAN EPIDERMAL CARCINOMA LARYNX CELLS-HEP-2 (K934243)Advanced Clinical Diagnostics1994-01-03
MCCOY CULTURE CELLS-MCCOY (K934241)Advanced Clinical Diagnostics1994-01-03
CYNOMOLOGUS MONKEY KIDNEY CELLS (K935336)Advanced Clinical Diagnostics1994-01-03
CBC-STK(TM) HEMATOLOGY CONTROL/MULTIPLE (K934497)R&D Systems, Inc.1993-12-06
APTT-ES REAGENT (K934351)Medical Diagnostic Technologies, Inc.1993-12-06
REFLOTRON HEMOGLOBIN TEST TABS (K934064)Boehringer Mannheim Corp.1993-12-06
SPECTROLYSE FACTOR VII:C (K934584)Meditech, Inc.1993-12-06
R & D BATTERIES, INC. PART NUMBERS 5296, 5479, 5351, & 5470 (K934747)R & D Batteries, Inc.1993-12-03
BATROXOBIN REAGENT (K932787)Behring Diagnostics, Inc.1993-11-29
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