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Hematology

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

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RecordFirmDate
H-Y MEDIUM (DME:NCTC109, 7:1 MIX.) HYBRI-MAX H9014 (K870487)Sigma Chemical Co.1987-03-30
VWF IMMUNOBLOT (K864701)Ramco Laboratories, Inc.1987-03-30
MEDIUM 199 WITH EARLE'S SALTS PRODUCT NO. M2520 (K870530)Sigma Chemical Co.1987-03-30
BGJB MED(FITTON JACKSON MOD)W/L-GLUT/W/O SOD BICAR (K870497)Sigma Chemical Co.1987-03-30
MCCOY 5A MED (MOD) SUUSPENSION CULTURE, M6523 (K870499)Sigma Chemical Co.1987-03-30
MSI HEMATOLOGY CONTROL + (K871067)Medical Specialties, Inc.1987-03-25
DEFINED CALF BOVINE SERUM SUPPLEMENTED #A-2151 (K870467)Hyclone Laboratories, Inc.1987-03-24
CHARACTERIZED FETAL BOVINE SERUM #A-1115 (K870464)Hyclone Laboratories, Inc.1987-03-24
ADULT BOVINE SERUM (K870468)Hyclone Laboratories, Inc.1987-03-24
DEFINED FETAL BOVINE SERUM #A-1111 (K870463)Hyclone Laboratories, Inc.1987-03-24
DEFINED CALF BOVINE SERUM #A-2111 (K870466)Hyclone Laboratories, Inc.1987-03-24
6/40 FETAL BOVINE SERUM #A-1110 (K870465)Hyclone Laboratories, Inc.1987-03-24
DEFINED EQUINE SERUM #A-3311 (K870469)Hyclone Laboratories, Inc.1987-03-24
WINPETTE (K871076)Ulster Scientific, Inc.1987-03-23
DR.BRUNO LANGE MINI-HBA1 PHOTOMETER (K865055)Diversa Corp.1987-03-19
COAG-A-MATE(R) XC (K870960)Organon Teknika Corp.1987-03-17
CELL-DYN 1600 MULTIPARAMETER AUTO. HEMA. ANALYZER (K870233)Abbott Diagnostics1987-03-17
HAEMOGLOBIN REAGENT - CYANMETHAEMOGLOBIN METHOD (K870363)Trace Scientific , Ltd.1987-03-16
CYTOSCAN (K864955)Image Recognition Systems , Ltd.1987-03-16
CHART-TYPE MICRO HEMATOCRIT TUBE READER (K870511)Norfolk Scientific, Inc.1987-03-16
IMMUNOADSORBED FACTOR X DEFICIENT PLASMA (HUMAN) (K870353)American Dade1987-02-10
IMMUNOADSORBED FACTOR V DEFICIENT PLASMA (HUMAN) (K870354)American Dade1987-02-10
ELECTRA(R) 800 AUTOMATIC COAGULATION TIMER (K864534)Medical Laboratory Automation Systems, Inc.1987-02-06
H-1 SETPOINT PLATELET AND RBC/WBC CALIBRATORS (K864664)Technicon Instruments Corp.1987-02-06
ELECTRA(R) 700 AUTOMATIC COAGULATION TIMER (K864532)Medical Laboratory Automation Systems, Inc.1987-02-06
LYMPHOCYTE MAINTENANCE MEDIUM (K864396)Bioclinical Laboratory Services, Inc.1987-02-02
IL TEST 84668-15, FACTOR VIII CONTROL PLASMA (K864480)Instrumentation Laboratory CO1987-01-21
COAGULATION EXTRINSIC DEFICIENT PLASMAS (K864497)Instrumentation Laboratory CO1987-01-05
IL TEST 97575-15, HEPARIN ASSAY (K864211)Instrumentation Laboratory CO1987-01-05
SORVALL CAPSPIN MICROHEMATOCRIT CENTRIFUGE (K864646)E.I. Dupont DE Nemours & Co., Inc.1987-01-05
BONE MARROW COLLECTION MEDIUM (K864740)Bioclinical Laboratory Services, Inc.1987-01-05
COAGULATION INTRINSIC DEFICIENT PLASMAS (K864481)Instrumentation Laboratory CO1987-01-05
PROTIME AUTOMATE TEST KIT (K864392)American Bioproducts Co.1987-01-05
A549 (HUMAN LUNG CARCINOMA) CULTURE CELLS (K864776)Bartels Immunodiagnostic Supplies, Inc.1986-12-31
TISSUE GRAM STAIN (K864531)Sigma Diagnostics, Inc.1986-12-22
HEMOCCULT WIPE TEST (K862849)Smithkline Diagnostics, Inc.1986-12-09
SIMPLASTIN EXCEL (K864283)Organon Teknika Corp.1986-12-04
IL TEST 84673-30 CHROMOGENICS CONTROL PLASMA (K864271)Instrumentation Laboratory CO1986-11-25
IL TEST 97572-15, ALPHA 2-ANTIPLASMIN ASSAY (K864213)Instrumentation Laboratory CO1986-11-25
IL TEST 97574-15M, ANTITTHROMBIN III ASSASY (K864214)Instrumentation Laboratory CO1986-11-25
ACUSYST-P (CELL CULTURE EQUIPMENT) (K864334)Endotronics, Inc.1986-11-24
THROMBOPLASTIN.R (K864274)American Dade1986-11-13
RAPID ACID FAST STAIN (K864033)Sigma Diagnostics, Inc.1986-11-13
THROMBOPLASTIN.C (K864273)American Dade1986-11-13
THROMBOPLASTIN.FS (K864272)American Dade1986-11-13
PIASTRINIT (K863114)J. D. Assoc.1986-11-06
NATURAL DETECTOR SYSTEM (K861731)U.S. Health Resources Corp.1986-11-06
TISSUE CULTURE FLASK (K864021)Fenwal Laboratories1986-10-29
ELASTIC STAIN (K864074)Sigma Diagnostics, Inc.1986-10-29
MICROHEMATOCRIT CENTRIFUGE (K864039)Plaza Medical, Inc.1986-10-29
HEMATALL-C PLUS HEMATOLOGY CONTROLS (K863224)Fisher Scientific Co., LLC1986-10-29
ASSERACHROM B-TG KIT (K862775)American Bioproducts Co.1986-10-22
ACTIN FSL ACTIVATED PTT REAGENT (K863594)American Dade1986-10-17
HISTAMINE RIA TEST FOR HISTAMINE BIOLOGICAL FLUIDS (K854236)Nms Pharmaceuticals, Inc.1986-10-10
HEMOLYSE (K863503)Reagent Laboratory, Inc.1986-10-03
COAGULATOR (8 CHANNEL) (K862047)Med USA1986-09-29
ARTHROSCOPIC SURGICAL POWER DEVICE (K863696)American Edwards Laboratories1986-09-29
ATAC 4300 HEMATOLOGY CELL COUNTER (K863332)Turpen Laboratory Systems, Inc.1986-09-29
ASSERACHROM D-DI KIT (K862156)American Bioproducts Co.1986-09-16
HEMOGLOBIN A1C BY COLUMN TEST (MICRO A1C) (K862371)Bio-Rad1986-09-16
TECHNICON H.1 SYSTEM, T LYMPHOCYTES METHOD (K860830)Technicon Instruments Corp.1986-09-08
CELLECT 8E AUTOMATED BLOOD CELL COUNTERS (K862374)Instrumentation Laboratory CO1986-09-04
IL CELLECT 7 (K863290)Instrumentation Laboratory CO1986-09-04
COULTER COUNTER MODEL T-540 (K863085)Coulter Electronics, Inc.1986-09-04
D-DI TEST KIT (K861973)American Bioproducts Co.1986-09-04
TOTAL HEMOGLOBIN (K863104)J. D. Assoc.1986-09-04
COULTER COUNTER MODEL T-890 (K863084)Coulter Electronics, Inc.1986-09-04
ASSERACHROM PF4 KIT (K862774)American Bioproducts Co.1986-09-04
IL CELLECT 8 (K863291)Instrumentation Laboratory CO1986-09-04
IL SYSTEM 810, ACL AND THE REAGENT SETS (K862301)Instrumentation Laboratory CO1986-09-03
CBC-CAL (TM) PLUS/MULTIPLE (K862858)R&D Systems, Inc.1986-08-21
U.S. DIAGNOSTIC INC. HEMOGLOBIN TEST (DRY PACK) (K862641)U. S. Diagnostics, Inc.1986-08-21
SELF ASSURE/GHB (CAPILLARY-BLOOD COLLECTION KIT) (K861697)Awareness Technology, Inc.1986-08-19
VISION(TM) HEMOGLOBIN (K862202)Abbott Laboratories1986-08-18
SANDARE GLYCOHEMOGLOBIN PROCEDURE (K862556)Sandare Chemical Co., Inc.1986-08-08
COULTER COUNTER MODEL S PLUS JUNIOR (K861780)Coulter Electronics, Inc.1986-08-06
PERCEPTIVE SYSTEMS INC PSICOM 217 KARYOTYPING SYST (K861974)Perceptive Systems, Inc.1986-08-04
BLOOD PLATELET ASSAY METHOD & APPARATUS (K862302)Bellhouse Medical, Inc.1986-07-31
KOAGULAB* M COAGULATION SYSTEM (K862537)Ortho Diagnostic Systems, Inc.1986-07-21
FISHER DIAGNOSTICS HEMATALL-C CALIBRATOR (K862318)Fisher Scientific Co., LLC1986-07-10
V-MARC 88A COMPUTER (K862089)V.Marc, A Div. of Pictorial, Inc.1986-07-10
HUMAN EPITHELOID CERVIX CARCINOMA CELLS (HELA) (K862555)Viromed Laboratories, Inc.1986-07-10
ANTI-LEU-12 B CELL REAGENT (K851639)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-07-02
LYPHOCHEK GLYCATED HEMOGLOBIN/WHOLE BLOOD/LEV.I&II (K862186)Bio-Rad1986-07-01
ASSERA-PLATE PROTEIN C KIT (K861475)American Bioproducts Co.1986-06-25
ASSERA-PLATE VWF KIT (K861417)American Bioproducts Co.1986-06-25
PTT AUTOMATE TEST KIT (K861190)American Bioproducts Co.1986-06-23
STACLOT PROTEIN C TEST KIT (K861079)American Bioproducts Co.1986-06-19
TISSUE CULTURE FLASK PL 732 PLASTIC ACCESSORY PROD (K862152)Travenol Laboratories, S.A.1986-06-16
DULBECCO'S MEM WITH 4.5 G/L GLUCOSE MEDIUM (K861996)Hazleton Research Products, Inc.1986-06-09
ERMA HB-METER MODEL 303N (K854687)Future Impex Corp.1986-06-04
TE-25 COAGURO METER (K854686)Future Impex Corp.1986-06-04
MEM GLASGOW POWDERED MEDIUM (K861887)Hazleton Research Products, Inc.1986-05-29
RPMI-1640 MEDIUM WITH 25MM HEPES BUFFER (K861875)Hazleton Research Products, Inc.1986-05-29
ISCOVE'S (MODIFIED) DULBECCO'S MEDIUM (K861872)Hazleton Research Products, Inc.1986-05-29
GENTAMICIN-50MG/ML (K861869)Hazleton Research Products, Inc.1986-05-29
DMEM & HAM'S F-12 (1:1) POWDERED MEDIUM (K861886)Hazleton Research Products, Inc.1986-05-29
MEM GLASGOW MEDIUM (K861873)Hazleton Research Products, Inc.1986-05-29
HIGH MOLECULAR WEIGHT KININOGEN(HMWK) DEF PLASMA (K861049)Sigma Chemical Co.1986-05-29
MEM ALPHA EAGLE MEDIUM (K861867)Hazleton Research Products, Inc.1986-05-29
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