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Hematology

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

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RecordFirmDate
THROMBO SCREEN SICKLE CELL ASSAY SET (K854079)Pacific Hemostasis1985-10-31
POLYCHROME IV STAIN (K854176)Devetec, Inc.1985-10-31
GRAM STAIN KIT (K853896)Sigma Diagnostics, Inc.1985-10-22
FETAL BOVINE/FETAL CALF SERUM, NEWBORN, HORSE, RAB (K853803)Z.L. Bocknek Laboratories, Inc.1985-10-15
COULTER COUNTER MODEL M5 (K853429)Coulter Electronics, Inc.1985-10-10
CITREX H (K853897)Bio/Data Corp.1985-10-10
PARA CHECK (AKA EIGHT CHECK-C) (K852992)Streck Laboratories, Inc.1985-10-10
FDP ASSAY-20 TEST KIT (K852848)American Bioproducts Co.1985-10-10
ADDITIONAL HEMOTEC HEPCON/SYS B-10 COAGULATION CAR (K853789)Hemotec, Inc.1985-10-04
ACA FIBRIN DEGRADATION PROD ANALYTICAL TEST PACK (K852520)E.I. Dupont DE Nemours & Co., Inc.1985-10-04
ADDITIONAL HEMOTEC ACT COAGULATION CARTRIDGES (K853198)Medical Device Consultants, Inc.1985-10-04
LODE COAGULOMETER MODEL LC-6 (K852450)Lode Corp.1985-09-30
MSI-HB HEMOGLOBIN CONTROL (K853776)Medical Specialties, Inc.1985-09-19
THROMBO SCREEEN FIBRIN DEGRADATION PRODUCT KIT (K852512)Pacific Hemostasis1985-09-17
CELL-DYN 2000 AUTOMATED MULTI-PARAMETER HEMATOLOGY (K852371)Abbott Diagnostics1985-09-17
CORNING CELL WELLS-MULTIPLE WELL PLATES (K853634)Corning Medical & Scientific1985-09-16
CELL-DYN BRAND HEMATOLOGY REAGENTS (K852372)Abbott Diagnostics1985-09-03
COULTER VOLUME ADAPTER (K851943)Coulter Electronics, Inc.1985-08-30
COAGULATION FACTOR VIII DEFICIENT SUBSTRATE PLASMA (K853462)American Dade1985-08-29
COAGULATION FACTOR IX DEFICIENT SUBSTRATE PLASMA (K853461)American Dade1985-08-29
FETAL BOVINE SERUM IN TRANSFER CONTAINER (K853441)Newport Biosystems, Inc.1985-08-26
NEWPORT MEDIA TRANSFER CONTAINER (K852532)Newport Bio Systems1985-08-22
GLYCO-SEP/ALC TEST KIT FOR SEPARAT OF HEMOGLOBIN (K852986)Clinical Technology Corp.1985-08-19
HEMATOLOGY STAIN PACK (K853241)Fisher Scientific Co., LLC1985-08-19
GENERAL DIAGNOSTICS COAG-A-MATE XC (K852843)Warner-Lambert Co.1985-08-13
COAGULATOR (K852492)Med USA1985-08-13
AURAMINE O FLUORESCENT MYCOBACTERIAL STAIN SET (K853081)Advanced Medical Technology, Inc.1985-08-13
ACRIDINE ORANGE FLUORESCENT STAIN (K853187)Advanced Medical Technology, Inc.1985-08-13
CALCIUM CHLORIDE (K853246)Bio/Data Corp.1985-08-13
DUPONT ACA FIBRIN DEGRADATION PROD CLOTTING TUBE (K852519)E.I. Dupont DE Nemours & Co., Inc.1985-08-12
DUPONT ACA FIBRIN OGEN DEGRAD-PRODUCTS CALIBRATOR (K852176)E.I. Dupont DE Nemours & Co., Inc.1985-08-12
PLASTINEX (K852484)Bio/Data Corp.1985-08-12
ULTRACLONE ECL-01-2200 CELL LINE (K853203)Earl-Clay Laboratories, Inc.1985-08-12
CITREX II (K853077)Bio/Data Corp.1985-08-12
CITREX I (K853076)Bio/Data Corp.1985-08-12
CEPHALINEX ACTIVATED PTT REAGENT (K852195)Bio/Data Corp.1985-08-12
CITREX III (K853078)Bio/Data Corp.1985-08-12
DIAMAT GLYCOSLATED HEMOGLOBIN ANALYZER SYSTEM (K851636)Bio-Rad1985-07-30
OSMOCEL 3 (K851843)Hematology Marketing Assoc.1985-07-30
COULTER CHANNELYZER 256 (K851736)Coulter Electronics, Inc.1985-07-30
MONITOR IV PLUS (K851669)Helena Laboratories1985-07-23
QUICK-COUNT HEMATOLOGY CONTROLS (K851663)Seragen Diagnostics, Inc.1985-07-23
SRT-SYSTEM (K852554)Microwave Development, Inc.1985-07-18
HEMOGLOBIN ANALYZER (K851467)Awareness Technology, Inc.1985-07-16
MICROSPIN MINICENTRIFUGE ITEM NO. 65204/94 (K852482)Em Diagnostic Systems, Inc.1985-07-15
CENTIFUGE, HEMATOCRIT & MICROSEDIMENTATION COMBINE (K852516)Whittaker General Medical1985-07-15
HEMOGLOBIN (K851432)Pointe Scientific, Inc.,1985-07-12
MCCOY'S 5A MEDIUM-LIQUID FORM (K852602)Mediatech, Inc.1985-07-12
BIOGLAS MICROCARRIER BEAD (K852506)Solohill Engineering, Inc.1985-07-12
TRI-COUNT (K851375)Hematology Marketing Assoc.1985-07-12
HEK (K852396)Viromed Laboratories, Inc.1985-07-12
CELLGRO(ISCOVE'S MEDIUM) MODIFICATION (K852485)Mediatech, Inc.1985-07-12
MDCK (K852394)Viromed Laboratories, Inc.1985-07-12
NIKON/JOYCE LOCK MAGICAN 2 CHROMOSOME SYS (K851508)Nikon, Inc.1985-07-12
MINK LUNG (K852395)Viromed Laboratories, Inc.1985-07-12
MCDB 201 MED CAT NO. M6770 W/ HEPES & W0/ BICARBON (K852568)Sigma Chemical Co.1985-07-12
CELLGRO WILLIAMS' MEDIUM E (K852475)Mediatech, Inc.1985-07-12
LASER PLATELETCAL/MULTIPLE (K852016)R&D Systems, Inc.1985-07-09
GLYCO-CHECK (K852111)Thyroid Diagnostics, Inc.1985-07-05
SDI PREPAX DILUKIT M. (K851320)Scientific Distributors, Inc.1985-07-05
PRECINORM HB (K852136)Boehringer Mannheim Corp.1985-07-05
AD150, AUTOMATED HEMATOLOGY DILUTOR (K852373)Abbott Diagnostics1985-07-05
DASS PACK (K851280)Dass, Inc.1985-07-05
ELECTRA 800 AUTOMATIC COAGULATION TIMER (K851169)Medical Laboratory Automation Systems, Inc.1985-06-24
GIBCO MYCOTECT 189-5670 (K851275)Gibco Laboratories Life Technologies, Inc.1985-06-21
EZ-DETECT VISUAL COLOR TEST FOR BLOOD IN STOOL (K850431)Nms Pharmaceuticals, Inc.1985-06-17
WESCOR STAIN PACK FOR MODEL 7100 AEROSPRAY SLIDE S (K852138)Canyon Diagnostics, Inc.1985-06-13
AGGRO/LINK COMPUTER INTERFACE (K851025)Chrono-Log Corp.1985-06-12
MCCOY GENCELLS (K852204)Genus Diagnostics1985-06-04
HEP-2 GENCELLS (K852206)Genus Diagnostics1985-06-04
CELLGRO (K852288)Mediatech, Inc.1985-06-04
RMK GENCELLS CULTURE SYSTEM (K852205)Genus Diagnostics1985-06-04
ACA ACTIVATED PARTIAL THROMBOPLASTIN TIME ANALYTIC (K851126)E.I. Dupont DE Nemours & Co., Inc.1985-05-29
DUPONT ACA PROTHROMBIN TIME/ACTIVATED PARTIAL THRO (K851127)E.I. Dupont DE Nemours & Co., Inc.1985-05-29
ACA PROTHROMBIN TIME ANALYTICAL TEST PACK (K851125)E.I. Dupont DE Nemours & Co., Inc.1985-05-29
METACHROME (K851174)Potomac Medical System1985-05-23
MCDB 302 MEDIUM, M2021 (K851862)Sigma Cell Culture Reagents1985-05-20
SYSMEX E-5000, FULLY AUTOMATED HEMATOLOGY SYS (K850354)Toa Medical Electronics USA, Inc.1985-05-20
NCTC-135 MEDIUM N3262 (K851863)Sigma Cell Culture Reagents1985-05-20
HEK GENCELLS (K851928)Genus Diagnostics1985-05-20
VERO GENCELLS (K851927)Genus Diagnostics1985-05-20
D-PBS, PRODUCTS NO. D5652 (K851606)Sigma Chemical Co.1985-05-15
MCDB 151 MEDIUM, PRODUCT NO. M6645 (K851607)Sigma Chemical Co.1985-05-15
MCDB-105 MED. M6395, W/L-GLUTAMINE, 25M M HERPES & (K851738)Sigma1985-05-15
MCDB-110 MED. M6520 W/L-GLUTAMINE-25M M HERPES & (K851737)Sigma1985-05-15
SFRE 199-2 MEDIUM, PRODUCTS NO. S2138 (K851609)Sigma Chemical Co.1985-05-15
SFRE199-1 MEDIUM PRODUCT NO. S 2013 (K851608)Sigma Chemical Co.1985-05-15
CRCM-30 MEDIUM PRODUCT NO. C5030 (K851604)Sigma Chemical Co.1985-05-15
SWIN'S S-77 MEDIUM, PRODUCTS S2513 (K851605)Sigma Chemical Co.1985-05-15
PLATELET AGGREGATION REAGENT (K850592)Chrono-Log Corp.1985-05-13
SYSMEX E-3000, FULLY AUTOMATED HEMATOLOGY SYS (K850171)Toa Medical Electronics USA, Inc.1985-05-13
CBC-PLT-4/MULTIPLE WHOLE BLOOD HEMATOLOGY CONTROL (K850755)R&D Systems, Inc.1985-05-13
MRC-5 GENCELLS (K851562)Genus Diagnostics1985-05-10
ULTRACLONE ECL-01-800 CELL LINE (K851545)Earl-Clay Laboratories, Inc.1985-05-10
WI-38 GENCELLS (K851561)Genus Diagnostics1985-05-10
PLASMA EXTRACTION SYSTEM (K850391)Hans J. Brouwers & Assoc.1985-05-10
RK GENCELLS (K851563)Genus Diagnostics1985-05-10
GENERAL DIAG. CHROMOSTRATE HEPARIN ASSAY (K850486)Warner-Lambert Co.1985-05-08
GEN. DIAG. CHROMOSTRATE REF. PLASMA (K850409)Warner-Lambert Co.1985-05-08
GEN. DIAG. CHROMOSTRATE ALPHA-2 ANTIPLASMIN ASSAY (K850411)Warner-Lambert Co.1985-05-08
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