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Hematology

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

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RecordFirmDate
THROMBOLYTIC ACTIVITY TEST (K834301)Bio/Data Corp.1984-02-04
PROTOPATH FACTOR IX ASSAY (K834050)American Dade1984-02-04
FIBRINOGEN TEST (K834571)Diatech, Inc.1984-02-04
WHITE BLOOD CELLS HUMAN TAND B (K833929)Control Diagnostics1984-02-03
CONTACT-K APTT REAGENT (K834086)Pacific Hemostasis1984-02-03
THROMBO PLUS (K834527)W. Sarstedt, Inc.1984-01-30
QUICK-COUNT (K833971)Seragen Diagnostics, Inc.1984-01-30
COATEST ANTIPLASMIN (K833890)Kabivitrum, Inc.1984-01-30
COATEST HEPARIN (K833891)Kabivitrum, Inc.1984-01-30
RDW PARAMETER FOR THE TECHNICON H6000 (K834026)Technicon Instruments Corp.1984-01-30
COATEST FACTOR VIII (K833892)Kabivitrum, Inc.1984-01-30
PROPPER SERACULT (K834297)Propper Mfg. Co., Inc.1984-01-27
ELTRACHEM DIATRAC GLYCOSYLATED HEMOGLOB (K834294)Emd Chemicals, Inc.1984-01-24
AUTO AIC ANALYZER SYSTEM (K833772)Helena Laboratories1984-01-18
ORTHO ELT-8/DS HEMATOLOGY ANALYZER (K833618)Ortho Diagnostic Systems, Inc.1984-01-13
HELENA BIO STRIP OB (K834456)Helena Laboratories1984-01-13
COULTER COUNTER MODEL S-PLUS V (K833600)Coulter Electronics, Inc.1984-01-10
COMPUR* M1000 HEMOGLOBIN & ERYTHROCYTE (K833708)Worthington Diagnostic Systems1984-01-04
HC PLUS (K833563)Coulter Electronics, Inc.1984-01-03
GLYCOGLOBIN KIT (K833805)Endocrine Sciences Products1984-01-03
MSI-HC HEMATOLOGY CONTROL (K834043)Medical Specialties, Inc.1984-01-03
FACTOR II DEFICIENT SUBSTRATE PLASMA (K834031)Helena Laboratories1983-12-16
QUICK STAIN WRIGHT'S GIEMSA W/BUFF (K833677)J.S. Medical Assoc.1983-11-25
HEMATOLOGY WRIGHT'S-GIEMSA SATIN PACK (K833665)J.S. Medical Assoc.1983-11-25
HEMATOLOGY WRIGHT'S STAIN PACK (K833678)J.S. Medical Assoc.1983-11-25
CLEX (K833463)Dextran Products, Ltd.1983-11-21
COLOSCREEN V.P.I. (K832864)Helena Laboratories1983-11-21
MEDIUM 199 W/EARLE'S SALTS W/L-GLUTAM (K833389)Sigma Chemical Co.1983-11-03
THROMBOPLASTIN - FS (K833272)American Dade1983-11-03
ISOTONIC BLOOD CELL DILUENT J & S (K833443)Jasins & Sayles Associates, Inc.1983-11-03
TYRODE'S SALT SOLUTION W/SODIUM BICAR (K833390)Sigma Chemical Co.1983-11-03
VEIGERT'S IRON HEMATOXYLIN STAIN-HT10-79 (K833424)Sigma Chemical Co.1983-11-03
LACTALBUMIN HYDROLYSATE MED. W/HANKS (K833391)Sigma Chemical Co.1983-11-03
ISCOE'S MOD. DULBECCO'S MED. W/GLUTAM (K833393)Sigma Chemical Co.1983-11-03
MEDIUM 199 W/HANK'S SALT W/L-GLUTAMINE (K833394)Sigma Chemical Co.1983-11-03
GLYCO-JE,E CPMTRP;-NORMAL/ABNORMAL (K833356)Helena Laboratories1983-11-03
WI-38 CELLS (K833359)Biocon, Inc.1983-11-03
GEN. DIAGNOSTICS LOW FIBRINOGEN CONTROL (K833352)Warner-Lambert Co.1983-11-03
LYSING & HEMOGLOBIN S-REAGENT J & S (K833444)Jasins & Sayles Associates, Inc.1983-11-03
HEP-2 CELLS (K833360)Biocon, Inc.1983-11-03
WAYMOUTH MB 752/1 MED. W/L-GLUTAMINE (K833392)Sigma Chemical Co.1983-11-03
MRC-5 CELLS (K833358)Biocon, Inc.1983-11-03
TRICHROME STAIN LG SOLUTION (K833167)Sigma Chemical Co.1983-10-31
MASSON TRICHROME STAIN HT15 (K833273)Sigma Chemical Co.1983-10-31
IRON STAIN PROCEDURE HT20 (K833388)Sigma Chemical Co.1983-10-31
FISHERS MED. FOR LEUKEMIC CELLS-MICE (K833165)Sigma Chemical Co.1983-10-28
STAIN PACK FOR AEROSPRAY SLIDE STAINER (K833260)Wescor, Inc.1983-10-28
MEM-EAGLE W/EARLES SALTS W/IVEAA (K833163)Sigma Chemical Co.1983-10-28
HEMOCUE PHOTOMETER TECHNICAL MANUAL (K832020)Aktiebolaget Leo Diagnostics1983-10-28
MEM-EAGLE-W/EARLES SALTS W/NEAA & (K833168)Sigma Chemical Co.1983-10-28
ERYTHROCYTE TEST (K832771)Bio-Analytics Laboratories, Inc.1983-10-28
MEM W/L-GLUTAMINE W/O SODIUM BICARBON (K833169)Sigma Chemical Co.1983-10-28
L-15-LEIBOVITZ W/L-GLUTAMINE-L4386 (K833164)Sigma Chemical Co.1983-10-27
ATAC 4700 HEMATOLOGY CELL COUNTER (K832116)Turpen Laboratory Systems, Inc.1983-10-20
TRI-COUNT 7 (K833130)Hematology Marketing Assoc.1983-10-20
PLATELET AGGREGATION REAGENT SET (K832428)Helena Laboratories1983-10-20
HEMACOMP 7 OR HEMATIL 7 (K832890)Texas Intl. Laboratories, Inc.1983-10-19
HEMOCHRON THROMBOCHRONOMETER (K832189)International Technidyne Corp.1983-10-14
EASYTOUCH TROMBOPLASTIN REAGENT (K832427)Worthington Diagnostic Systems1983-10-14
TISSUE TRANSPORT MEDIUM (K833016)Northern Scientific, Inc.1983-10-14
DIACROM * HEPARIN (K832373)Wellcome Diagnostics1983-09-29
DIACROM * FACTOR X KIT HA31 (K832372)Wellcome Diagnostics1983-09-29
MUCICARMINE STAIN, #HT30 (K832953)Sigma Chemical Co.1983-09-29
RISTOCETIN PLATELET AGGREGA-REAGENT TEST (K832929)Sigma Chemical Co.1983-09-29
A-GENT GLYCOSYLATED HEMOGLOBIN (K832775)Abbott Laboratories1983-09-29
DIACROM * ATIII (K832592)Wellcome Diagnostics1983-09-29
ORTHO CELL CULTURES-MRC-5 HUMAN EMBRYO (K832947)Ortho Diagnostic Systems, Inc.1983-09-29
DULBECCOS MODIFIED EAGLES MEDIUM D5648 (K832842)Sigma Chemical Co.1983-09-29
SPINNER SALT SOLUTION S-6011 W/EARLES (K832930)Sigma Chemical Co.1983-09-29
NUTRIENT MIXTURE F12 #N6760 W/L-GLUTAM (K832841)Sigma Chemical Co.1983-09-29
DULBECCOS PHOSPHATE BUFFERED SALINE (K832835)Sigma Chemical Co.1983-09-29
BASAL MED. #B9763 W/HANKS SALTS W/L-G (K832836)Sigma Chemical Co.1983-09-29
CELL-DYN 900 HEMATOLOGY ANALYZER (K832643)Abbott Diagnostics1983-09-26
EARLES BALANCED SALT MIXTURE #E6132 (K832838)Sigma Chemical Co.1983-09-26
EASYTOUCH HEMOGLOBIN REAGENT (K832750)Worthington Diagnostic Systems1983-09-26
NUTRIENT MIXTURE F-10 #N6635 W/L-GLUTA (K832837)Sigma Chemical Co.1983-09-26
MINIMUM ESSENTIAL MED. EAGLE M4642 W/ (K832840)Sigma Chemical Co.1983-09-26
HANKS BALANCED SALT MIXTURE H6136 (K832839)Sigma Chemical Co.1983-09-26
BIO SURE STAIN (K832496)Helena Laboratories1983-09-12
BASAL MED. EAGLE #B9888 W/L-GLUTAMINE (K832687)Sigma Chemical Co.1983-09-12
MCCOY'S 5A #M4892 W/L-GLUTAMINE AND (K832689)Sigma Chemical Co.1983-09-12
TECHNICON H6000 SYSTEM (K832627)Technicon Instruments Corp.1983-09-12
MINIMUM ESSENTIAL MED. EAGLE M0268 (K832690)Sigma Chemical Co.1983-09-12
DULBECCO'S MODIFIED EAGLE #D5523- (K832688)Sigma Chemical Co.1983-09-12
FACS ANALYZER (K832420)Bd Becton Dickinson Vacutainer Systems Preanalytic1983-09-01
MONOJET SAMPLETTE ADAPTERS (K832578)Sherwood Medical Co.1983-08-31
COATEST FACTOR X (K832114)Kabivitrum, Inc.1983-08-26
TITAN GEL GLYCO-HEME SYSTEM (K832087)Helena Laboratories1983-08-24
LYSING REAGENT (K832182)Omega Medical Diagnostics1983-08-12
RABBIT ANTI-HUMAN ANTITHROMBIN III (K832268)Gelco Diagnostics, Inc.1983-08-12
ORTHO ABNORMAL COAGULATION LEVEL I/II (K832225)Ortho Diagnostic Systems, Inc.1983-08-12
IMMUNODIFFUSION TEST HUMAN ANTITHROMBIN (K831961)Kent Laboratories, Inc.1983-08-11
QUANTIGEN T & B CELL ASSAY (K831053)Bio-Rad1983-08-08
CLINOVATIVE II DIAGNOSTIC KIT (K831837)Pierce Chemical Co.1983-08-01
CO-OXIMETER CONTROL (K831813)United Diagnostics, Inc.1983-07-28
CALIBRATION STANDARD-HEMOGLOBIN (K831814)United Diagnostics, Inc.1983-07-28
SICKLE-HEME A/S CONTROLS & A/A CONTROL (K831871)Anco Medical Reagents & Assoc.1983-07-28
ELT-8/DS HEMATOLOGY ANALYZER & LYSRIG (K831271)Ortho Diagnostic Systems, Inc.1983-07-26
CALIBRATOR 282 (K831872)Bionostics, Inc.1983-07-18
CELL-DYN 400 HEMOTOLOGY ANALYZER (K831368)Abbott Diagnostics1983-07-18
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