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Hematology

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

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RecordFirmDate
ONE DRAM SHELL VIAL, CATALOG #02-321 (K930368)Proteins Intl., Inc.1993-03-23
25 CM2, 75 CM2, 150 CM2 FLASK, CATALOG #03-421 (K930383)Proteins Intl., Inc.1993-03-23
ORTHO(TM) RECOMBIPLASTIN W/ORTHO DILUENT (K925604)Ortho Diagnostic Systems, Inc.1993-03-12
VARIANT BETA-THALASSEMIA SHORT PROGRAM (K924122)Bio-Rad1993-03-11
FIBRINOGEN RID TEST KIT (K922416)The Binding Site, Ltd.1993-03-09
MULTIFIBREN (K925988)Behring Diagnostics, Inc.1993-03-01
CRYP CHECK IN-VITRO COAGULATION CONTROL SYSTEM (K922887)Precision Biologicals, Inc.1993-02-25
NYCOPLASTIN (K920767)Nycomed Pharma AS1993-02-12
OWREN'S VERONAL BUFFER #5375 & FIBRONOGEN KIT#5376 (K926222)Helena Laboratories1993-02-12
CYTO-STAT/COULTER CLONE CD 3(IGG1)-FITC/T8-RD1 (K922744)Coulter Immunology1993-02-05
BIOVATION K-MANAGER (K925528)Biovation, Inc.1993-02-05
SPUNCRIT (K925863)bioMerieux, Inc.1993-02-05
CYTO-STAT/COULTER CLONE CD3(IGG1)-FITC/T4-RD1 (K922745)Coulter Immunology1993-02-05
CELLEXIS HEMATOLOGY ANALYZER (K923773)Technalysis, Inc.1993-02-05
BIOMERIEUX HEMOLAB THROMBOMAT (K925492)Biomerieux Vitek, Inc.1993-02-03
HEMOCHRON CITRA ONESTEP APTT/FAC VI SINGSHOT APTT (K924637)International Technidyne Corp.1993-01-27
COULTER NEW METH BLUE PREPREP RETIC/MAXM W/AUTOLOA (K925344)Coulter Corp.1993-01-21
ITC MICROSAMPLE COAGULATION ANALYZER SYSTEM (K923761)International Technidyne Corp.1993-01-21
HEMOCHRON DIRECT DRAW APTT/FAC VI VACU-APTT (K924638)International Technidyne Corp.1993-01-14
VARIANT SICKLE CELL SHORT PROGRAM (K924813)Bio-Rad1993-01-14
IL TEST(TM) PRO-CHROM (K924884)Instrumentation Laboratory CO1993-01-14
BECKMAN DIATRAC HEMOGLOB A1C ELECTRO KIT, MODIFIED (K925204)Beckman Instruments, Inc.1993-01-12
DADE HEPZYME (K925452)Baxter Diagnostics, Inc.1993-01-11
MSI-HCT (K924926)Medical Specialties, Inc.1993-01-07
CD4 CYTOSPHERES KIT (K921279)Coulter Electronics, Inc.1992-12-29
STACLOT LA TEST KIT (K923731)American Bioproducts Co.1992-12-23
CALCIUM CHLORIDE/DIETHYLBARB ACETATE BUFF SOLUTION (K924509)Behring Diagnostics, Inc.1992-12-21
MULTI-CHANNEL DISCRETE ANALYZER (MDA-180) (K924453)Organon Teknika Corp.1992-12-18
LEUCOPREP(R) BRAND CELL SEPARAT TUBE W/SODIUM CITR (K911731)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-12-15
CYTOQUANT MCCOY CELLS 25CM2/75CM2 FLASK/#03-301 (K924613)Proteins Intl., Inc.1992-12-07
CYTOQUANT A-549 CELLS, 16X125 MM TUBE #01-201 (K924624)Proteins Intl., Inc.1992-12-07
COAMATE PROTEIN C CHROMOGENIC ASSAY (K922201)Chromogenix AB1992-12-07
CYTOQUANT HEP-2 CELLS 25CM/75CM/175CM FLASK#03-251 (K924618)Proteins Intl., Inc.1992-12-07
CYTOQUANT A-549 CELLS, CATALOG #02-201 (K924622)Proteins Intl., Inc.1992-12-07
CYTOQUANT HEP-2 CELLS, CATALOG #02-251 (K924616)Proteins Intl., Inc.1992-12-07
NEOPLASTINE(R) CI KIT (K922565)American Bioproducts Co.1992-12-07
CYTOQUANT MRC-5 CELLS 16 X 125 MM TUBE, #01-101 (K924619)Proteins Intl., Inc.1992-12-07
CYTOQUANT HLNFS CELLS, CATLOG #03-151 (K924625)Proteins Intl., Inc.1992-12-07
CYTOQUANT MRC-5 CELLS, CATALOG #03-101 (K924620)Proteins Intl., Inc.1992-12-07
CYTOQUANT HEP-2 CELLS 16 X 125 MM TUBE, #01-251 (K924617)Proteins Intl., Inc.1992-12-07
CYTOQUANT H292 CELLS 25CM2/75CM2/175CM2 FLASK (K924615)Proteins Intl., Inc.1992-12-07
CYTOQUANT MRC-5 CELLS, CATALOG #02-101 (K924621)Proteins Intl., Inc.1992-12-07
CYTOQUANT MCCOY CELLS/ONE DRAM SHELL VIAL #02-301 (K924612)Proteins Intl., Inc.1992-12-07
CYTOQUANT A-549 CELLS, CATALOG #03-201 (K924623)Proteins Intl., Inc.1992-12-07
CYTOQUANT HNFS CELLS (K924595)Proteins Intl., Inc.1992-12-07
CYTOQUANT H292 HUMAN PULM MUCOEPIDER CARCIN CELLS (K924614)Proteins Intl., Inc.1992-12-07
CONTROL PLASMA P (K924405)Behring Diagnostics, Inc.1992-12-01
BEHRING FIBRINTIMER A (K924124)Behring Diagnostics, Inc.1992-12-01
HEMOCARD(TM) CONTROL (K924173)Isolab, Inc.1992-12-01
CLIBRATION PLASMAS (K924404)Behring Diagnostics, Inc.1992-12-01
CLOTTING FACTOR V DEFICIENT PLASMA (K924394)Behring Diagnostics, Inc.1992-12-01
CRITERION, HEMOCUE B-HEMOGLOBIN CONTROL (K921681)Isolab, Inc.1992-11-17
QC-CHEX (K923971)Streck Laboratories, Inc.1992-11-16
STANDARD HUMAN PLASMA (K924393)Behring Diagnostics, Inc.1992-11-16
ENZYGNOST F 1+2 (K922934)Behring Diagnostics, Inc.1992-11-16
GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KIT (K924496)Drew Scientific , Ltd.1992-11-16
COAG-CONTROL [N] KIT (K922174)American Bioproducts Co.1992-10-26
IL TEST PT FIBRINOGEN HS (K923921)Instrumentation Laboratory CO1992-10-26
PLATELIN L (K921396)Organon Teknika Corp.1992-10-19
MINUTEX D-DIMER LATEX TEST (K920668)Biopool AB1992-10-16
COULTER MULTI-Q-PREP (K923530)Coulter Electronics, Inc.1992-10-14
SPECTROLYSE/PL PAI KIT (K922782)Biopool AB1992-10-09
PROPPER SUPER SERACULT(R) (K921798)Propper Mfg. Co., Inc.1992-10-05
IMX(R) GLYCATED HEMOGLOBIN (K921831)Abbott Laboratories1992-09-29
THROMBIN CLOT TIME TEST PROCEDURE (K923220)Medical Laboratory Automation Systems, Inc.1992-09-29
NEW STACHROM ANTIPLASMIN (K921449)American Bioproducts Co.1992-09-23
HEMOCHRON/FACTOR VI FIBRINOGEN ASSAY AND CONT PLAS (K923593)International Technidyne Corp.1992-09-22
QBC HEMACAN HEMATOLOGY SYSTEM (K923121)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-09-22
CLOTTRAC COAGULATION CONTROL (K923594)Medtronic Hemotec, Inc.1992-09-21
TECHNICON H*2 (K923237)Heraeus Kulzer, Inc.1992-09-11
KOAGULAB CTS CHROMOGRNIC TESTING SYSTEM (K914188)Ortho Diagnostic Systems, Inc.1992-08-26
PLATELET AGGREGATION REAGENTS (K922800)Chrono-Log Corp.1992-08-26
COLUMNMATE BETA THAL HBA2 CONTROL-ABNORMAL (K923317)Helena Laboratories1992-08-25
COLUMNMATE BETA-THAL HBA2 CONTROL - NORMAL (K923318)Helena Laboratories1992-08-25
ACS FREEZE-DRIED APTT REAGENT (K921223)Analytical Control Systems, Inc.1992-08-18
COULTER MH009 (K922181)Coulter Electronics, Inc.1992-08-17
MODIFICATION COLUMNMATE (K920820)Helena Laboratories1992-08-17
IL TEST(TM) ALPHA-2-ANTIPLASMIN ASSAY SYSTEM (K920012)Instrumentation Laboratory CO1992-08-12
FIBRINOSTIKA TDP MICROELISA SYSTEM (K915698)Organon Teknika Corp.1992-08-05
REFLAB SYSTEM PACK LIQUID FRUCTOSAMINE REAGENT (K920397)Medical Analysis Systems, Inc.1992-08-04
MONOMCLONAL ANTIBODY IGG1 ISOTYPE CONT. FLOW CYTOM (K922084)Gen Trak, Inc.1992-07-28
ACS APCT REAGENT (K921118)Analytical Control Systems, Inc.1992-07-28
MONOCLONAL ANTIBODY IGG2A ISOTYPE CONT. FLOW CYTOM (K922085)Gen Trak, Inc.1992-07-28
POINTE 750 GLYCOMETER (K920449)Pointe Scientific, Inc.,1992-07-28
COULTER MAXM W/ AUTOLOADER (K922704)Coulter Electronics, Inc.1992-07-27
DADE RECOMBOPLASTIN S (K921326)Baxter Diagnostics, Inc.1992-07-27
GLYCOMAT HAEMOGLOBIN ANALYSER (K920198)Drew Scientific , Ltd.1992-07-21
DIA STRIPS SYSTEM, MODIFIED (K921495)Symcon Intl., Inc.1992-07-21
HMS PURPLE AND BLACK HEPARIN CARTRIDGES & CONTROL (K922031)Medtronic Hemotec, Inc.1992-07-21
FDP PLASMA TEST KIT (K920943)American Bioproducts Co.1992-07-13
COLUMNMATE II (K921676)Helena Laboratories1992-07-10
COULTER MH017 (K921567)Coulter Electronics, Inc.1992-07-06
CAT. NO. 1471 (110V) & CAT. NO. 1472 (220V) (K921465)Helena Laboratories1992-06-29
IVOS ANALYZER (K920719)Hamilton Thorne Research1992-06-29
QBC FIBRINOGEN (K920258)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-06-26
NEOPLASTINE CI PLUS (K922040)American Bioproducts Co.1992-06-23
CD8 MONOCLONAL ANTIBODIES (K914847)Gen Trak, Inc.1992-06-19
CD4 MONOCLONAL ANTIBODIES (K914848)Gen Trak, Inc.1992-06-19
CD2 MONOCLONAL ANTIBODIES (K914846)Gen Trak, Inc.1992-06-19
MIL CM-II COAGULATION MACHINE (K913320)Medical Innovations Corp.1992-06-16
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