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Review Panel

Hematology FDA 510(k) Clearances & Devices

Cleared Devices
4,197
Product Codes (page)
50
Latest Decision
1988-05-02

Clearances · page 26 of 42

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K881161 TECH-CAL(TM)/MULTIPLE R&D Systems, Inc. KSA Class II 1988-05-02
K880616 MINOS AUTOMATIC CELL COUNTER Abx, Inc. GKZ Class II 1988-05-02
K880700 ENZYGNOST(R) TAT REAGENTS Behring Diagnostics, Inc. JBQ Class II 1988-04-27
K880038 FOR THE DETER. OF HEMOGLOBIN IN PLASMA #527 Sigma Diagnostics, Inc. KHG Class II 1988-04-21
K881242 CELL-DYN RAPID-LYSE AND HEMOGLOBLIN Abbott Diagnostics GJZ Class II 1988-04-21
K880653 HBF DILUENT Helena Laboratories KQI Class II 1988-04-21
K881465 CRYOBIOLOGICAL FREEZER Cryodyne Technologies, Inc. KSP Class I 1988-04-21
K881512 WESCOR GRAM STAIN PACK FOR MODEL 7300 AEROSPRAY Wescor, Inc. JTS Class I 1988-04-18
K881466 CELL-CULTURE SHAKER Cryodyne Technologies, Inc. KJB Class I 1988-04-18
K875221 TOOTH PRESERVING SYSTEM Biological Rescue Products, Inc. KJF Class I 1988-04-14
K875346 AUTOLYZER 801 SYSTEM (AUTOMATED CELL COUNTER) Contraves Medical Instruments, Inc. GKZ Class II 1988-04-07
K873428 GLYCO-PROBE GSP Isolab, Inc. LCP Class II 1988-04-05
K881287 ANIMAL AND HUMAN SERA Cell Culture Laboratories KIS Class I 1988-04-05
K880471 BOVINE CALF SERUM SUPPLEMENTED #A-2159 Hyclone Laboratories, Inc. KIS Class I 1988-04-04
K880507 COULTER VCS LEUKOCYTE DIFFERENTIAL COUNTER Coulter Electronics, Inc. GKZ Class II 1988-04-04
K880544 WESCOR STAIN CONCENTRATE FOR MODEL 7100 AEROSPRAY Wescor, Inc. GJL Class I 1988-04-01
K880470 BOVINE CALF SERUM CATALOG #A-2119 Hyclone Laboratories, Inc. KIS Class I 1988-04-01
K880509 MULTISURFACE ROLLER BOTTLE (M.S.R.B.) Motil Plastics , Ltd. KJC Class I 1988-04-01
K881130 CELL-DYN ISOTONIC DILUENT Abbott Diagnostics GIF Class I 1988-03-31
K880691 EARLE'S BALANCED SALTS W/OUT PHENOL RED & SODIUM Sigma Chemical Co. KIT Class I 1988-03-31
K880596 EOSIN Y SOLUTION, ALCOHOLIC, WITH PHLOXINE Sigma Chemical Co. HYB Class I 1988-03-31
K881042 ATS TRICHROME STAIN (WHEATLEY'S MODIFICATION) Alpha-Tec Systems, Inc. JTS Class I 1988-03-30
K881150 KINETIC FIBRINOGEN ASSAY Bio/Data Corp. GIS Class II 1988-03-28
K880718 CALCOFLUOR WHITE STAIN KIT Remel Co. JTS Class I 1988-03-25
K880999 EPIPACK Clonetics Corp. KIT Class I 1988-03-24
K880566 CLP PROTHROMBIN TIME TEST Creative Laboratory Products, Inc. GJS Class II 1988-03-23
K881068 CLP ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST Creative Laboratory Products, Inc. GFO Class II 1988-03-23
K880636 RETICCOUNT SOFTWARE Bd Becton Dickinson Vacutainer Systems Preanalytic GKL Class II 1988-03-21
K880608 MSI-PC Medical Specialties, Inc. GJP Class II 1988-03-21
K881000 KERATINOCYTE GROWTH MEDIUM (KGM) Clonetics Corp. KIT Class I 1988-03-21
K880711 CLP 0.02 M CALCIUM CHLORIDE SOLUTION. Creative Laboratory Products, Inc. GIT Class II 1988-03-18
K880713 CLP 0.1 M SODIUM CITRATE SOLUTION Creative Laboratory Products, Inc. JPA Class II 1988-03-18
K880373 IONOMETER E-HK AND ACCESSORIES Smash Ent., Inc. GKF Class II 1988-03-17
K880874 IMMUNOADSORBED FACTOR VII DEFICIENT PLASMA HUMAN Baxter Healthcare Corp GJT Class II 1988-03-17
K880315 DADE ANTITHROMBIN III CHROMOGENIC ASSAY Baxter Healthcare Corp JBQ Class II 1988-03-16
K875089 HEPCON SYSTEM B-10 ACTIVATED CLOT TIME & HEPARIN Hemotec, Inc. JPA Class II 1988-03-09
K875047 COULTER CLONE T11 MONOCLONAL ANTIBODY Coulter Electronics, Inc. GKZ Class II 1988-03-09
K880240 INSTANT EOSIN-ALCOHOLIC Shandon, Inc. HYB Class I 1988-03-03
K880270 MSI-DIFF PLUS Medical Specialties, Inc. JPK Class II 1988-03-01
K875102 DETER. OF HEMOGLOBIN A2 USING THE DIAMAT Bio-Rad JPD Class II 1988-02-24
K880292 FACTOR VIII REFERENCE PLASMA Helena Laboratories GJT Class II 1988-02-19
K880302 CALCIUM CHLORIDE SOLUTION 0.1M, IN HEPES BUFFER Hemotec, Inc. GGN Class II 1988-02-19
K874838 COULTER COUNTER MODEL T SERIES W/2-PART DIFFERENT. Coulter Electronics, Inc. GKZ Class II 1988-02-19
K874763 CELLECT MODEL D, AUTOMATED HEMTALOGY ANALYZER Instrumentation Laboratory CO GKZ Class II 1988-02-18
K875354 UNISTEP CAPILLARY BLOOD COLLECTION SYSTEM Ulster Scientific, Inc. LCP Class II 1988-02-17
K874328 L-PHENYLALANINE METHYL ESTER HYDROCHLORIDE PME REA E.I. Dupont DE Nemours & Co., Inc. JCF Class I 1988-02-16
K875062 EASY-TEST PROTHROMBIN TIME PT ITEM NO. 16628 Em Diagnostic Systems, Inc. GJS Class II 1988-02-11
K873409 WAKO(TM) PRETEST 6A Wako Chemicals USA, Inc. KHE Class II 1988-02-11
K880077 FIBRINOSTICON Organon Teknika Corp. GHH Class II 1988-02-09
K874940 CALIBRATION REFERENCE PLASMA Baxter Healthcare Corp GGP Class II 1988-02-09
K875310 RETICULOCYTE STAIN Sigma Diagnostics, Inc. KFC Class I 1988-02-09
K874592 THROMBOPLASTIN.C Baxter Healthcare Corp GJS Class II 1988-02-04
K874429 HEMOGLOBIN DETERMINATION TEST KIT HGB S-100 & 12 Hf Scientific, Inc. GIQ Class II 1988-02-04
K874320 CELLECT LABTRAK SOFTWARE Instrumentation Laboratory CO GKL Class II 1988-01-27
K874188 COULTER IMMUNOPREP LEUKOCYTE/Q-PREP IMMUNO WRK STA Coulter Electronics, Inc. GKM Class I 1988-01-19
K875061 MONOJECT SAMPLETTE AMBER CAPILLARY SERUM SEPARATOR Sherwood Medical Co. GIO Class I 1988-01-12
K875151 ACUSYST-P/3X Endotronics, Inc. KJH Class I 1988-01-12
K874147 QBC BLOOD BANK SYSTEM Bd Becton Dickinson Vacutainer Systems Preanalytic GKZ Class II 1988-01-11
K874373 PT PRO-CLOT Probe-Tek, Inc. JBR Class II 1988-01-05
K874436 FLUID SAMPLING PACK U.S. Mfg. & Management, Inc. KSS Class I 1988-01-05
K874427 QBC SYSTEM HEMOGLOBIN Bd Becton Dickinson Vacutainer Systems Preanalytic GKZ Class II 1988-01-05
K874386 CBC-TECH(TM) HEMATOLOGY CONTROL/MULTIPLE R&D Systems, Inc. JCN Class II 1987-12-30
K854010 FRUCTOSAMINE TEST (ROCHE) Roche Diagnostic Systems, Inc. LCP Class II 1987-12-22
K871420 HERPES 1 AND 2 MICROASSAYS Diamedix Corp. GGC Class II 1987-12-11
K874097 STACHROM VIII:C TEST KIT American Bioproducts Co. GGP Class II 1987-12-03
K873889 TISSUE CULTURE TUBES Nunc, Inc. KJA Class I 1987-11-25
K873890 TISSUE CULTURE FLASKS Nunc, Inc. KJA Class I 1987-11-25
K873734 SYSMEX F-800 15 PARAMETER, SEMI-AUTO HEMA ANALYZER Toa Medical Electronics USA, Inc. GKZ Class II 1987-11-25
K873891 TISSUE CULTURE DISHES Nunc, Inc. KIZ Class I 1987-11-25
K874662 MYCO-FLUOR REAGENT A & B Scott Laboratories, Inc. JTS Class I 1987-11-25
K873832 REAGENTS FOR USE ON CONTRAVES DC300, DC500, AL801 In Vitro Diagnostics, Inc. KRZ Class II 1987-11-23
K873382 PLATELET EXTRACT REAGENT Bio/Data Corp. GGW Class II 1987-11-20
K872145 CELLSOFT(TM)-CASA (SERIES 1000,2000 & 3000) Cryo Corp. GKL Class II 1987-11-13
K873256 MICRO-COUNT DIFFHE Toni Diagnostics, Inc. GKZ Class II 1987-11-06
K873252 DIGICELL 500 Contraves Medical Instruments, Inc. GKL Class II 1987-11-06
K873172 HAMILTON-THORN MOTILITY ANALYZER HTM-2000 Hamilton Thorne Research GKL Class II 1987-11-06
K873271 DIGICELL 300 SYSTEM Contraves Medical Instruments, Inc. GKL Class II 1987-11-06
K873185 DYNABEADS HLA CELL PREP II ISOLATION PRODUCT Dynal Biotech, Inc. JCF Class I 1987-11-04
K873647 VENTRESCREEN CAPILLARY BLOOD COLLECTION TUBE Ventrex Laboratories, Inc. GIO Class I 1987-10-20
K873625 CHEMELIA ENZYME IMMUNOASSAY FOR (TSH) Boots-Celltech Diagnostics, Inc. JLM Class II 1987-10-20
K874054 FISHER DIAGNOSTICS HEMATALL III LAS REAGENT Fisher Scientific Co., LLC GGK Class I 1987-10-20
K873413 GRAM CRYSTAL VIOLET/IODINE/ACETON ALCHL DECLR/SAFR Lakewood Biochemical Co., Inc. JTS Class I 1987-10-06
K872775 LEUCOPREP BRAND TUBE Bd Becton Dickinson Vacutainer Systems Preanalytic JCF Class I 1987-10-02
K872166 FACSCAN FLOW CYTOMETER - RETICCOUNT RETI. ENU. KIT Bd Becton Dickinson Vacutainer Systems Preanalytic GKL Class II 1987-09-30
K872852 EAGLE DIAGNOSTICS GLYCOHEMOGLOBIN UNITIZED TEST Sandare Chemical Co., Inc. LCP Class II 1987-09-29
K873354 QBC VENOUS BLOOD CONTROL/MULTIPLE R&D Systems, Inc. JPK Class II 1987-09-29
K873304 CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES) Miles Laboratories, Inc. LJX Class I 1987-09-11
K873348 CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG. Abbott Diagnostics GGK Class I 1987-09-09
K873347 CELL-DYN DIFF. SCREEN ISOTONIC DILUENT Abbott Diagnostics GIF Class I 1987-09-09
K871830 NAPSAC(TM) Beecher Medical Diagnostic Instrumentation GKL Class II 1987-09-09
K872941 SPECTRO C Ramco Laboratories, Inc. GGP Class II 1987-09-04
K872755 KARYOTEC 100 Amcor Electronics, Ltd. LNJ Class II 1987-09-01
K873103 TECHNICON H*1 JR.(TM) SYSTEM Technicon Instruments Corp. GKL Class II 1987-08-28
K872537 PROTHROMBIN TIME TEST Sclavo, Inc. GJS Class II 1987-08-27
K873095 (MEM) EAGLE NO. M3149 W/HANKS' SALTS Sigma Chemical Co. KIT Class I 1987-08-25
K873094 (MEM) EAGLE NO. M7399 W/EARLE'S SALTS Sigma Chemical Co. KIT Class I 1987-08-25
K873091 AMES' MEDIUM NO. A1420 W/L-GLUTA. W.O/SOD. BICARB. Sigma Chemical Co. KIT Class I 1987-08-25
K873090 MEDIUM 199 NO. M3274 W/HANKS' SALTS W.O/L-GLUTAMI. Sigma Chemical Co. KIT Class I 1987-08-25
K873092 RPMI-1640 MEDIUM NO. R7755 AUTO-MOD(TM) W.O/L-GLU. Sigma Chemical Co. KIT Class I 1987-08-25
K873093 (MEM) EAGLE NO. M3024 W/EARLE'S SALTS Sigma Chemical Co. KIT Class I 1987-08-25

4,197 clearances in the Hematology panel. Data: openFDA.