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Hematology

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

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RecordFirmDate
HBF DILUENT (K880653)Helena Laboratories1988-04-21
CELL-DYN RAPID-LYSE AND HEMOGLOBLIN (K881242)Abbott Diagnostics1988-04-21
CRYOBIOLOGICAL FREEZER (K881465)Cryodyne Technologies, Inc.1988-04-21
FOR THE DETER. OF HEMOGLOBIN IN PLASMA #527 (K880038)Sigma Diagnostics, Inc.1988-04-21
CELL-CULTURE SHAKER (K881466)Cryodyne Technologies, Inc.1988-04-18
WESCOR GRAM STAIN PACK FOR MODEL 7300 AEROSPRAY (K881512)Wescor, Inc.1988-04-18
TOOTH PRESERVING SYSTEM (K875221)Biological Rescue Products, Inc.1988-04-14
AUTOLYZER 801 SYSTEM (AUTOMATED CELL COUNTER) (K875346)Contraves Medical Instruments, Inc.1988-04-07
GLYCO-PROBE GSP (K873428)Isolab, Inc.1988-04-05
ANIMAL AND HUMAN SERA (K881287)Cell Culture Laboratories1988-04-05
BOVINE CALF SERUM SUPPLEMENTED #A-2159 (K880471)Hyclone Laboratories, Inc.1988-04-04
COULTER VCS LEUKOCYTE DIFFERENTIAL COUNTER (K880507)Coulter Electronics, Inc.1988-04-04
MULTISURFACE ROLLER BOTTLE (M.S.R.B.) (K880509)Motil Plastics , Ltd.1988-04-01
WESCOR STAIN CONCENTRATE FOR MODEL 7100 AEROSPRAY (K880544)Wescor, Inc.1988-04-01
BOVINE CALF SERUM CATALOG #A-2119 (K880470)Hyclone Laboratories, Inc.1988-04-01
EOSIN Y SOLUTION, ALCOHOLIC, WITH PHLOXINE (K880596)Sigma Chemical Co.1988-03-31
CELL-DYN ISOTONIC DILUENT (K881130)Abbott Diagnostics1988-03-31
EARLE'S BALANCED SALTS W/OUT PHENOL RED & SODIUM (K880691)Sigma Chemical Co.1988-03-31
ATS TRICHROME STAIN (WHEATLEY'S MODIFICATION) (K881042)Alpha-Tec Systems, Inc.1988-03-30
KINETIC FIBRINOGEN ASSAY (K881150)Bio/Data Corp.1988-03-28
CALCOFLUOR WHITE STAIN KIT (K880718)Remel Co.1988-03-25
EPIPACK (K880999)Clonetics Corp.1988-03-24
CLP ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST (K881068)Creative Laboratory Products, Inc.1988-03-23
CLP PROTHROMBIN TIME TEST (K880566)Creative Laboratory Products, Inc.1988-03-23
KERATINOCYTE GROWTH MEDIUM (KGM) (K881000)Clonetics Corp.1988-03-21
MSI-PC (K880608)Medical Specialties, Inc.1988-03-21
RETICCOUNT SOFTWARE (K880636)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-03-21
CLP 0.02 M CALCIUM CHLORIDE SOLUTION. (K880711)Creative Laboratory Products, Inc.1988-03-18
CLP 0.1 M SODIUM CITRATE SOLUTION (K880713)Creative Laboratory Products, Inc.1988-03-18
IONOMETER E-HK AND ACCESSORIES (K880373)Smash Ent., Inc.1988-03-17
IMMUNOADSORBED FACTOR VII DEFICIENT PLASMA HUMAN (K880874)Baxter Healthcare Corp1988-03-17
DADE ANTITHROMBIN III CHROMOGENIC ASSAY (K880315)Baxter Healthcare Corp1988-03-16
HEPCON SYSTEM B-10 ACTIVATED CLOT TIME & HEPARIN (K875089)Hemotec, Inc.1988-03-09
COULTER CLONE T11 MONOCLONAL ANTIBODY (K875047)Coulter Electronics, Inc.1988-03-09
INSTANT EOSIN-ALCOHOLIC (K880240)Shandon, Inc.1988-03-03
MSI-DIFF PLUS (K880270)Medical Specialties, Inc.1988-03-01
DETER. OF HEMOGLOBIN A2 USING THE DIAMAT (K875102)Bio-Rad1988-02-24
CALCIUM CHLORIDE SOLUTION 0.1M, IN HEPES BUFFER (K880302)Hemotec, Inc.1988-02-19
FACTOR VIII REFERENCE PLASMA (K880292)Helena Laboratories1988-02-19
COULTER COUNTER MODEL T SERIES W/2-PART DIFFERENT. (K874838)Coulter Electronics, Inc.1988-02-19
CELLECT MODEL D, AUTOMATED HEMTALOGY ANALYZER (K874763)Instrumentation Laboratory CO1988-02-18
UNISTEP CAPILLARY BLOOD COLLECTION SYSTEM (K875354)Ulster Scientific, Inc.1988-02-17
L-PHENYLALANINE METHYL ESTER HYDROCHLORIDE PME REA (K874328)E.I. Dupont DE Nemours & Co., Inc.1988-02-16
WAKO(TM) PRETEST 6A (K873409)Wako Chemicals USA, Inc.1988-02-11
EASY-TEST PROTHROMBIN TIME PT ITEM NO. 16628 (K875062)Em Diagnostic Systems, Inc.1988-02-11
FIBRINOSTICON (K880077)Organon Teknika Corp.1988-02-09
CALIBRATION REFERENCE PLASMA (K874940)Baxter Healthcare Corp1988-02-09
RETICULOCYTE STAIN (K875310)Sigma Diagnostics, Inc.1988-02-09
THROMBOPLASTIN.C (K874592)Baxter Healthcare Corp1988-02-04
HEMOGLOBIN DETERMINATION TEST KIT HGB S-100 & 12 (K874429)Hf Scientific, Inc.1988-02-04
CELLECT LABTRAK SOFTWARE (K874320)Instrumentation Laboratory CO1988-01-27
COULTER IMMUNOPREP LEUKOCYTE/Q-PREP IMMUNO WRK STA (K874188)Coulter Electronics, Inc.1988-01-19
MONOJECT SAMPLETTE AMBER CAPILLARY SERUM SEPARATOR (K875061)Sherwood Medical Co.1988-01-12
ACUSYST-P/3X (K875151)Endotronics, Inc.1988-01-12
QBC BLOOD BANK SYSTEM (K874147)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-01-11
QBC SYSTEM HEMOGLOBIN (K874427)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-01-05
PT PRO-CLOT (K874373)Probe-Tek, Inc.1988-01-05
FLUID SAMPLING PACK (K874436)U.S. Mfg. & Management, Inc.1988-01-05
CBC-TECH(TM) HEMATOLOGY CONTROL/MULTIPLE (K874386)R&D Systems, Inc.1987-12-30
FRUCTOSAMINE TEST (ROCHE) (K854010)Roche Diagnostic Systems, Inc.1987-12-22
HERPES 1 AND 2 MICROASSAYS (K871420)Diamedix Corp.1987-12-11
STACHROM VIII:C TEST KIT (K874097)American Bioproducts Co.1987-12-03
SYSMEX F-800 15 PARAMETER, SEMI-AUTO HEMA ANALYZER (K873734)Toa Medical Electronics USA, Inc.1987-11-25
TISSUE CULTURE FLASKS (K873890)Nunc, Inc.1987-11-25
MYCO-FLUOR REAGENT A & B (K874662)Scott Laboratories, Inc.1987-11-25
TISSUE CULTURE DISHES (K873891)Nunc, Inc.1987-11-25
TISSUE CULTURE TUBES (K873889)Nunc, Inc.1987-11-25
REAGENTS FOR USE ON CONTRAVES DC300, DC500, AL801 (K873832)In Vitro Diagnostics, Inc.1987-11-23
PLATELET EXTRACT REAGENT (K873382)Bio/Data Corp.1987-11-20
CELLSOFT(TM)-CASA (SERIES 1000,2000 & 3000) (K872145)Cryo Corp.1987-11-13
DIGICELL 300 SYSTEM (K873271)Contraves Medical Instruments, Inc.1987-11-06
HAMILTON-THORN MOTILITY ANALYZER HTM-2000 (K873172)Hamilton Thorne Research1987-11-06
DIGICELL 500 (K873252)Contraves Medical Instruments, Inc.1987-11-06
MICRO-COUNT DIFFHE (K873256)Toni Diagnostics, Inc.1987-11-06
DYNABEADS HLA CELL PREP II ISOLATION PRODUCT (K873185)Dynal Biotech, Inc.1987-11-04
VENTRESCREEN CAPILLARY BLOOD COLLECTION TUBE (K873647)Ventrex Laboratories, Inc.1987-10-20
CHEMELIA ENZYME IMMUNOASSAY FOR (TSH) (K873625)Boots-Celltech Diagnostics, Inc.1987-10-20
FISHER DIAGNOSTICS HEMATALL III LAS REAGENT (K874054)Fisher Scientific Co., LLC1987-10-20
GRAM CRYSTAL VIOLET/IODINE/ACETON ALCHL DECLR/SAFR (K873413)Lakewood Biochemical Co., Inc.1987-10-06
LEUCOPREP BRAND TUBE (K872775)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-10-02
FACSCAN FLOW CYTOMETER - RETICCOUNT RETI. ENU. KIT (K872166)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-09-30
EAGLE DIAGNOSTICS GLYCOHEMOGLOBIN UNITIZED TEST (K872852)Sandare Chemical Co., Inc.1987-09-29
QBC VENOUS BLOOD CONTROL/MULTIPLE (K873354)R&D Systems, Inc.1987-09-29
CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES) (K873304)Miles Laboratories, Inc.1987-09-11
NAPSAC(TM) (K871830)Beecher Medical Diagnostic Instrumentation1987-09-09
CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG. (K873348)Abbott Diagnostics1987-09-09
CELL-DYN DIFF. SCREEN ISOTONIC DILUENT (K873347)Abbott Diagnostics1987-09-09
SPECTRO C (K872941)Ramco Laboratories, Inc.1987-09-04
KARYOTEC 100 (K872755)Amcor Electronics, Ltd.1987-09-01
TECHNICON H*1 JR.(TM) SYSTEM (K873103)Technicon Instruments Corp.1987-08-28
PROTHROMBIN TIME TEST (K872537)Sclavo, Inc.1987-08-27
RPMI-1640 MEDIUM NO. R7755 AUTO-MOD(TM) W.O/L-GLU. (K873092)Sigma Chemical Co.1987-08-25
(MEM) EAGLE NO. M7399 W/EARLE'S SALTS (K873094)Sigma Chemical Co.1987-08-25
(MEM) EAGLE NO. M3149 W/HANKS' SALTS (K873095)Sigma Chemical Co.1987-08-25
MEDIUM 199 NO. M3274 W/HANKS' SALTS W.O/L-GLUTAMI. (K873090)Sigma Chemical Co.1987-08-25
AMES' MEDIUM NO. A1420 W/L-GLUTA. W.O/SOD. BICARB. (K873091)Sigma Chemical Co.1987-08-25
(MEM) EAGLE NO. M3024 W/EARLE'S SALTS (K873093)Sigma Chemical Co.1987-08-25
IN VITRO 2.5X ROLLER BOTTLE (K873137)In Vitro Scientific Products1987-08-24
RPMI-1640 MEDIUM (HAT MODIFIED) NO. 200-2080 (K873084)J R Scientific1987-08-21
INSTANT HEMATOXYLIN (K873107)Shandon, Inc.1987-08-21
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