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Hematology

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

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RecordFirmDate
TECHNICON H*1 SYSTEMS, LABFACTS SOFTWARE FOR U.I.W. VERSIONS 4.11 & 5.11 (K933478)Miles, Inc.1993-11-22
TECHNICON H* 2 SYSTEM, LABFACTS SOFTWARE FOR U.I.W. VERSIONS 4.11 & 5.11 (K933475)Miles, Inc.1993-11-22
STAGO FACTOR IX-DEFICIENT PLASMA (K933432)American Bioproducts Co.1993-11-15
TAS ANALYZER (K933092)Cardiovascular Diagnostic Services1993-11-15
GLYCOHEMOGLOBIN (K931183)Teco Diagnostics1993-11-05
NEW STACHROM PROTEIN C TEST KIT (K931906)American Bioproducts Co.1993-11-05
FDP - SLIDEX DIRECT (K921989)Biomerieux Vitek, Inc.1993-11-03
CA-1000 AUTOMATED COAGULATION ANALYZER (K931149)Toa Medical Electronics USA, Inc.1993-11-03
AGGRO/LINK CONTROL SOFTWARE (K932566)Chrono-Log Corp.1993-11-02
FIBRIN(OGEN) FDP CONTROL LEVEL 1 & LEVEL 2 (K932657)More Diagnostics1993-11-02
STAGO FACTOR XI-DEFICIENT PLASMA (K933444)American Bioproducts Co.1993-10-27
STAGO FACTOR X-DEFICIENT PLASMA (K933441)American Bioproducts Co.1993-10-27
STAGO FACTOR XII-DEFICIENT PLASMA (K933438)American Bioproducts Co.1993-10-27
STAGO FACTOR VII-DEFICIENT PLASMA (K933440)American Bioproducts Co.1993-10-27
PATHROMTIN (K932011)Behring Diagnostics, Inc.1993-10-25
COAGULATION REFERENCE PLASMA, NORMAL (K932145)American Diagnostic Corp.1993-10-18
IL TEST (TM) PT-FIBRINOGEN HS PLUS (K933252)Instrumentation Laboratory CO1993-10-04
TRACE TRANSFERRIN REAGENT (K932713)Trace Scientific , Ltd.1993-09-30
BIOCLOT LA (K932463)Biopool AB1993-09-27
DADE (PAI-1) CHROMOGENIC ASSAY DADE COAGTROL-PAI (K933188)Baxter Diagnostics, Inc.1993-09-22
BIOMERIEUX HEMOLAB COFAC VIII (K933010)Biomerieux Vitek, Inc.1993-09-15
745 GLYCOMAT (K933287)Drew Scientific , Ltd.1993-09-09
HEMOCHRON/FACTOR VI WHOLE BLOOD FACTOR VIII ASSAY (K930235)Technidyne Corp.1993-09-02
HEMOCHRON MODEL 8000/FACTOR VI PREMIER COAGULATION (K930068)Technidyne Corp.1993-09-02
FACSORT FLOW CYTOMETER (K923790)Becton Dickinson Immunocytometry Systems1993-09-01
COULTER MH015 (DIFFERENTIAL CELL COUNTER) (K930913)Coulter Corp.1993-08-23
CASCADE M, CAT. NO. 1710 (K931956)Helena Laboratories1993-08-23
COULTER STKS WITH RETICULOCYTE ANALYSIS CAPABILITY (K932030)Coulter Corp.1993-08-23
ELECTRA 1600C AUTOMATIC COAGULATION TIMER (K931206)Medical Laboratory Automation Systems, Inc.1993-08-23
PROTEIN-BOUND GLUCOSE ASSAYN KIT (K930823)Diagnostic Specialties1993-08-19
REP HEMOGLOBIN IEF KITS (CAT. NO. 3250) (K931503)Helena Laboratories1993-08-16
SICKLE CELL TEST KIT (K932872)Histo-Med, Inc.1993-08-16
IL TEST FIBRINOGEN-C (K931721)Instrumentation Laboratory CO1993-08-13
STACLOT(R) PNP TEST KIT (K924370)American Bioproducts Co.1993-08-09
BOEHRINGER MANNHEIM COAGUCHEK SYSTEM (K930454)Boehringer Mannheim Corp.1993-08-05
SIMULTEST CD3/ANTI-HLA-DR (K924587)Becton Dickinson Immunocytometry Systems1993-08-05
IMS-200 (K925670)Intelligent Medica Imaging, Inc.1993-07-23
QUANTIKINE(TM) ERYTHROPOIETIN/ENZ LINK IMMUN ASSAY (K931666)R&D Systems, Inc.1993-07-20
ABBOTT ENCOUNTER(TM)Q (K930309)Abbott Laboratories1993-07-14
REP ALKALINE HB-15 #3196,-8 #3197,-4 3198 (K931465)Helena Laboratories1993-07-06
CYTO-STAT/COULTER CLONE CD3 (IGG1)-FITC/B4-RD1 MON (K926124)Coulter Corp.1993-07-06
BERICHROM HEPARIN (K925200)Behring Diagnostics, Inc.1993-06-28
PREDICTA ERYTHROPOIETIN KIT (K926390)Genzyme Corp.1993-06-25
TECHNICON H* 3TM RTC SYSTEM (IN-VITRO DIAG.SYST.) (K930685)Heraeus Kulzer, Inc.1993-06-22
IL MCL-2 COAGULATION ANALYZER (K924098)Instrumentation Laboratory CO1993-06-18
CHECKPOINT (K931947)Medical Specialties, Inc.1993-06-18
CLOTTING FACTOR-11,-VII, -X DEFICIENT PLASMA (K924400)Behring Diagnostics, Inc.1993-06-08
VISTA(R) HUMAN FOLLICLE-STIM HORMONE(HFSH) ASSAY (K926422)Syva Co.1993-06-02
CLOTTING FACTOR-VIII-IX-XI-XII DEFICIENT PLASMA (K924396)Behring Diagnostics, Inc.1993-05-21
FACTOR CONTROL [P] (K930959)American Bioproducts Co.1993-05-20
BIOMERIEUX HEMOLAB FIBRINOMAT (K925494)Biomerieux Vitek, Inc.1993-05-18
TEST THROMBIN (K930157)Behring Diagnostics, Inc.1993-05-14
THROMBOPLATIN-M WITH CALCIUM (K930212)Sigma Diagnostics, Inc.1993-05-11
HEMOCARD CONTROL HB-AA, AE, FAA, FAE (K931234)Isolab, Inc.1993-05-11
TECHNICON H* 3 RTX SYSTEM (IN-VITRO DIAG. SYSTEM) (K930148)Heraeus Kulzer, Inc.1993-05-11
CRIT-LINE (K924167)Noninvasive Medical Technology Corp.1993-05-07
ACS APCT REAGENT, MODIFIED (K926012)Analytical Control Systems, Inc.1993-04-27
COAG-CONTROL (K930923)American Bioproducts Co.1993-04-27
VERIFY REFERENCE PLASMA AND MDA VERIFY REF. PLASMA (K930849)Organon Teknika Corp.1993-04-20
IL TEST(TM) PROTEIN S (K930327)Instrumentation Laboratory CO1993-04-12
LUPO-TEST REGEANT (K922326)Graoipore , Ltd.1993-04-06
LUCOR CONFIRMATORY REAGENT (K922156)Gradipore , Ltd.1993-04-06
COULTER RETIC-C CELL CONTROL (K930119)Coulter Electronics, Inc.1993-04-05
VARIANT(TM) HEMOGLOBIN A 1C PROGRAM (K926469)Bio-Rad1993-03-29
16 X 125 MM TEST TUBE, CATALOG #01-111 (K930392)Proteins Intl., Inc.1993-03-24
16 X 125 MM TEST TUBE, CATALOG #01-441 (K930398)Proteins Intl., Inc.1993-03-24
25 CM2, 75 CM2, A50 CM2 FLASK, CATALOG #03-211 (K930394)Proteins Intl., Inc.1993-03-24
25 CM2, 75 CM2, 125 CM2 FLASK, CATALOG #03-291 (K930390)Proteins Intl., Inc.1993-03-24
25 CM2, 75 CM2, 150 CM2 FLASK, CATALOG #03-261 (K930391)Proteins Intl., Inc.1993-03-24
16 X 125 MM TEST TUBE, CATALOG (K930397)Proteins Intl., Inc.1993-03-24
ONE DRAM SHELL VIAL, CATALOG #02-261 (K930393)Proteins Intl., Inc.1993-03-24
16 X 125 MM TEST TUBE, CATALOG #01-291 (K930396)Proteins Intl., Inc.1993-03-24
ONE DRAM SHELL VIAL, CATALOG #02-461 (K930395)Proteins Intl., Inc.1993-03-24
25CM, 75CM, 150CM, FLASK, CATALOG #03-311 (K930369)Proteins Intl., Inc.1993-03-23
ONE DRAM SHELL VIAL, CATALOG #02-441 (K930381)Proteins Intl., Inc.1993-03-23
ONE DRAM SHELL VIAL, CATALOG #02-401 (K930387)Proteins Intl., Inc.1993-03-23
ONE DRAMSHELL VIAL, CATALOG #02-421 (K930382)Proteins Intl., Inc.1993-03-23
25CM2, 75CM2, 150CM2 FLASK, CATALOG #03-241 (K930365)Proteins Intl., Inc.1993-03-23
25 CM2, 75 CM2, 150 CM2 FLASK, CATALOG #03-401 (K930384)Proteins Intl., Inc.1993-03-23
25 CM2, 75 CM2, 150 CM2 FLASK, CATALOG #03-441 (K930378)Proteins Intl., Inc.1993-03-23
ONE DRAM SHELL VIAL, CATALOG #02-111 (K930373)Proteins Intl., Inc.1993-03-23
16 X 125 MM TEST TUBE, CATALOG #01-421 (K930385)Proteins Intl., Inc.1993-03-23
16 X 125 MM TEST TUBE, CATALOG #01-241 (K930388)Proteins Intl., Inc.1993-03-23
ONE DRAM SHELL VIAL, CATALOG #02-281 (K930379)Proteins Intl., Inc.1993-03-23
ONE DRAM SHELL VIAL, CATALOG # 02-241 (K930364)Proteins Intl., Inc.1993-03-23
CYTOQUANT(TM) MDCK CANINE KIDNEY CELLS (K930325)Proteins Intl., Inc.1993-03-23
ONE DRAM SHELL VIALS, CATALOG #02-311 (K930370)Proteins Intl., Inc.1993-03-23
25 CM2, 75 CM2, 150 CM2, FLASK, CATALOG #03-111 (K930374)Proteins Intl., Inc.1993-03-23
25 CM2, 75 CM2, 150 CM2 FLASK, CATALOG #03-461 (K930377)Proteins Intl., Inc.1993-03-23
ONE DRAM SHELL VIAL, CATALOG #02-291 (K930389)Proteins Intl., Inc.1993-03-23
COAGULATION CONTROL CONTAINING HEMOGLOBIN (K925340)Analytical Control Systems, Inc.1993-03-23
16 X 125 MM TEST TUBE, CATALOG #01-321 (K930371)Proteins Intl., Inc.1993-03-23
ONE DRAM SHELL VIAL, CATALOG #02-211 (K930376)Proteins Intl., Inc.1993-03-23
16 X 25 MM TEST TUBE, CATALOG #01-461 (K930366)Proteins Intl., Inc.1993-03-23
25CM2. 75CM2, 150 CM, FLASK, CATALOG #03-321 (K930367)Proteins Intl., Inc.1993-03-23
16 X 125 MM TEST TUBE, CATALOG #01-311 (K930372)Proteins Intl., Inc.1993-03-23
16 X 125 MM TEST TUBE, CATALOG #01-261 (K930380)Proteins Intl., Inc.1993-03-23
16 X 125 MM TEST TUBE, CATALOG #01-401 (K930386)Proteins Intl., Inc.1993-03-23
16 X 125 MM TEST TUBE, CATALOG #01-211 (K930375)Proteins Intl., Inc.1993-03-23
MICROHEMATOCRIT ROTOR (K930415)Fisher Scientific Co., LLC1993-03-23
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