meddevicedb.com FDA Device Reference

Review Panel

Hematology FDA 510(k) Clearances & Devices

Cleared Devices
4,197
Product Codes (page)
37
Latest Decision
1994-11-21

Clearances · page 17 of 42

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K941872 SPECIALTY ASSAYED CONTROL-2 CAT. NO. 5302 Helena Laboratories GGC Class II 1994-11-21
K942797 MONOCLONAL MOUSE ANTI-HUMAN T-CELL Dako Corp. GKZ Class II 1994-11-10
K933086 AFSC HEMO CONTROL #5331, AA2 HEMO CONTROL #5328 Helena Laboratories JCM Class II 1994-10-31
K941291 MONOJECT SAMPLETTE SEPARATOR TUBE Sherwood Medical Co. GIO Class I 1994-10-27
K925909 GENESIS 1, AUTOMATED CELL COUNTER, MODIFICATION Alicia Diagnostics, Inc. GKZ Class II 1994-10-27
K940957 HEMOCHRON VERIGY SYSTEM/FACTOR VI QUALIFY SYSTEM International Technidyne Corp. JPA Class II 1994-10-18
K940792 AGGRO/LINK VW COFACTOR SOFTWARE Chrono-Log Corp. JOZ Class II 1994-10-13
K934070 TINA-QUANT HEMOGLOBIN A1C Boehringer Mannheim Corp. LCP Class II 1994-10-11
K942822 CBC-LINE HEMATOLOGY LINEARITY CONTROL R&D Systems, Inc. JPK Class II 1994-10-07
K941737 SPECIALTY ASSAYED CONTROL-1 Helena Laboratories GIZ Class II 1994-10-07
K925274 AUTOCOMP(TM) SOFTWARE AND CALIBRITE(TM) BEADS Becton Dickinson Immunocytometry Systems GKZ Class II 1994-09-30
K943787 AURATEK FDP Organon Teknika Corp. DAP Class II 1994-09-20
K940426 MEDTRONIC HEMOTEC ACT II AUTOMATED COAGULATION TIMER Medtronic Hemotec, Inc. GKN Class II 1994-09-20
K935254 DVVTEST AND DVVCONFIRM LUPUS ANTICOAGULANT NORMAL AND ABNORMAL CONTROL PLASMA American Diagnostica, Inc. GIZ Class II 1994-09-19
K941860 SPECIALTY ASSAYED REFERENCE PLASMA (S.A.R.P.) Helena Laboratories GGN Class II 1994-09-14
K942009 PRIMUS RAPID GEL 100 GLYCATED HEMOGLOBIN ASSAY Primus Corp. LCP Class II 1994-09-14
K933486 FASCOUNT SYSTME Becton Dickinson Immunocytometry Systems GKZ Class II 1994-09-09
K934741 LIQUID FIBRINOGEN FDP CONTROL LEVEL 1 & 2 Clinical Controls, Inc. GIL Class II 1994-09-08
K915229 SEMEN ANALYSIS KIT Humagen Fertility Diagnostics, Inc. POV Class II 1994-08-30
K941001 ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KIT Diagnostic Specialties GIS Class II 1994-08-30
K936271 FRESH CELLS MULTI-WELL PLATE CULTURES AND SHELL VIAL CULTURE Diagnostic Hybrids, Inc. KIR Class I 1994-08-26
K940840 ACT CONTROL SET Sigma Diagnostics, Inc. JPA Class II 1994-07-19
K936016 QUANTIKINE IVD ERYTHROPOIETIN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) R&D Systems, Inc. GGT Class II 1994-07-19
K940971 AMES DCA 2000 HEMOGLOBIN ALC CONTROLS Heraeus Kulzer, Inc. LCP Class II 1994-07-19
K941007 CATALOG NO. J-ACT+ & QC-ACT+ International Technidyne Corp. JBP Class II 1994-06-30
K940502 FRESH FROZEN CELLS Diagnostic Hybrids, Inc. KIR Class I 1994-06-16
K942209 LIQUICHEK HEMATOLOGY-16 CONTROL, LOW, NORMAL AND HIGH Bio-Rad JCN Class II 1994-06-16
K931825 CD-CHEX CD4 LOW Streck Laboratories, Inc. GGL Class II 1994-06-06
K940432 MICROCOAGULATION PROTHROMBIN TIME TEST International Technidyne Corp. GJS Class II 1994-05-18
K935308 ACCUCOLOR(TM) ANTITHROMBIN III CHROMOGENIC ASSAY Sigma Diagnostics, Inc. JBQ Class II 1994-05-17
K940401 JR. MICROCOAGULATION SYSTEM International Technidyne Corp. JPA Class II 1994-05-11
K934274 HEMOLAB HEPARICHROM ASSAY Biomerieux Vitek, Inc. KFF Class II 1994-05-06
K936196 ANTITHROMBIN III CHROMOGENIC ASSAY Baxter Diagnostics, Inc. JBQ Class II 1994-05-04
K931420 COATEST(R) ANTITHROMBIN III, MODIFICATION Kabi Pharmacia Hepar, Inc. JBQ Class II 1994-05-02
K936023 SYSMEX SE-9000 AUTOMATED HEMATOLOGY ANALYZER Toa Medical Electronics USA, Inc. GKZ Class II 1994-05-02
K923951 CD8 CYTOSPHERES KIT Coulter Electronics, Inc. MAM Class II 1994-04-25
K924892 FIBRINOSTIKA(R) FGDP MICROELISA SYSTEM Organon Teknika Corp. DAT Class II 1994-04-21
K931756 QUANTIKINE(TM) ERYTHROPOIETIN HUMAN SERUM CONTROLS R&D Systems, Inc. GGT Class II 1994-04-21
K925493 BIOMERIEUX HEMOLAB THROMBICALCI-TEST Biomerieux Vitek, Inc. GJA Class II 1994-04-21
K940310 HELENA THROMBOPLASTIN-MI REAGENT Helena Laboratories GJS Class II 1994-04-20
K933125 BERICHROM ANTITHROMBIN III (A) Behring Diagnostics, Inc. JPE Class II 1994-04-19
K934326 MULTIFIBREN U Behring Diagnostics, Inc. KQJ Class II 1994-04-19
K935196 PARA 5 DIFF Streck Laboratories, Inc. JPK Class II 1994-04-05
K935613 RADIAS MONOCLONAL HBA 1C ASSAY Bio-Rad LCP Class II 1994-04-05
K933836 HBM HEMOGLOBINOMETER Artel, Inc. GIG Class II 1994-03-31
K933927 HEP-2 CULTURE CELL Neogenex KIR Class I 1994-03-31
K933228 KAPTON PEEL POUCH American Fluoroseal Corp. KJA Class I 1994-03-30
K931117 ASSESS(TM) LOW ABNORMAL CONTROL Instrumentation Laboratory CO GJS Class II 1994-03-30
K934539 THE YELLOW IRIS URINALYSIS WORKSTATION WITH IRISCOPE BODY FLUID ANALYSIS CAPABILITY Intl. Remote Imaging Systems GKL Class II 1994-03-30
K931118 ASSESS(TM) HIGH ABNORMAL CONTROL Instrumentation Laboratory CO GJS Class II 1994-03-30
K933925 MRC-5 CULTURE CELL Neogenex KIR Class I 1994-03-29
K933926 LLCMK2 CULTURE CELLS Neogenex KIR Class I 1994-03-29
K933923 A549 CULTURE CELL Neogenex KIR Class I 1994-03-29
K933924 MCCOY CULTURE CELL Neogenex KIR Class I 1994-03-29
K940089 CBC-COBAS 5 HEMATOLOGY CONTROL/MULTIPLE R&D Systems, Inc. JPK Class II 1994-03-22
K930267 BIOMERIEUX UNIPLASMATROL NORMAL & ABNORMAL Biomerieux Vitek, Inc. GGC Class II 1994-03-22
K933277 COAGULATION A.R.P. Helena Laboratories GGN Class II 1994-03-22
K936204 GLYCATED HEMOGLOBIN CALIBRATORS Primus Corp. LCP Class II 1994-03-22
K935057 FACTOR VIII DEFICIENT PLASMA Sigma Diagnostics, Inc. GJT Class II 1994-03-15
K940143 GLYCATED HEMOGLOBIN CONTROLS Primus Corp. LCP Class II 1994-03-15
K935953 COULTER MULTI Q PREP Coulter Corp. GKH Class I 1994-03-11
K932650 ERYTHROPOIETIN IMMUNOASSAY KIT Nichols Institute GGT Class II 1994-03-11
K940181 SE-CHECK Streck Laboratories, Inc. JPK Class II 1994-03-09
K935054 FACTOR X DEFICIENT PLASMA Sigma Diagnostics, Inc. GJT Class II 1994-03-07
K935058 FACTOR Sigma Diagnostics, Inc. GJT Class II 1994-03-07
K935056 FACTOR VII DEFICIENT PLASMA Sigma Diagnostics, Inc. GJT Class II 1994-03-07
K934606 STAGO FACTOR II-DEFICIENT PLASMA American Bioproducts Co. GJT Class II 1994-03-01
K934605 STAGO FACTOR V-DEFICIENT PLASMA American Bioproducts Co. GJT Class II 1994-03-01
K934314 TINTELIZER(R) TPA Biopool AB GGP Class II 1994-02-23
K924403 CONTROL PLASMA N Behring Diagnostics, Inc. GIZ Class II 1994-02-22
K924402 CONTROL PLASMA U Behring Diagnostics, Inc. GGC Class II 1994-02-22
K924401 PATHOPLASMA(R) I & II (PATH CITRATED HUMAN PLASMA) Behring Diagnostics, Inc. GGC Class II 1994-02-22
K935212 IL TEST HEPARIN (XA), PN 84699-15 Instrumentation Laboratory CO KFF Class II 1994-02-07
K936171 TRANSFORMED PRIMARY HUMAN EMBRYONAL KIDNEY Advanced Clinical Diagnostics KIR Class I 1994-02-03
K931241 FAST'N'FLAMMATORY KIT Techlab, Inc. GIA Class I 1994-02-03
K936172 RHESUS MONKEY KIDNEY CELLS (LLC-MK2) Advanced Clinical Diagnostics KIR Class I 1994-02-03
K936169 RHESUS MONKEY KIDNEY CELLS Advanced Clinical Diagnostics KIR Class I 1994-02-03
K934934 RABBIT KIDNEY CELLS - R.K.C. Advanced Clinical Diagnostics KIR Class I 1994-01-28
K934973 HELA-229/HELA CELLS Advanced Clinical Diagnostics KIR Class I 1994-01-28
K935343 CENTRIFIQ BLOOD CONTROL Hematronix, Inc. JPK Class II 1994-01-27
K925617 MDA PROTEIN ASSAY Organon Teknika Corp. GGP Class II 1994-01-27
K923153 HEMOCARD, HEMOGLOBIN C ASSAY Isolab, Inc. MLL Class II 1994-01-27
K923499 SPECTROLYSE HEPARIN KIT Biopool AB KFF Class II 1994-01-27
K933886 TOA MEDICAL ELECTRONICS CA-5000 Toa Medical Electronics USA, Inc. JPA Class II 1994-01-27
K935766 PRIMARY AFRICAN GREEN MONKEY KIDNEY CELLS Advanced Clinical Diagnostics KIR Class I 1994-01-24
K935337 RHABDOMYOSARCOMA CELLS Advanced Clinical Diagnostics KIR Class I 1994-01-03
K934244 HUMAN LUNG DIPLOID CELLS-MRC-5 Advanced Clinical Diagnostics KIR Class I 1994-01-03
K934243 HUMAN EPIDERMAL CARCINOMA LARYNX CELLS-HEP-2 Advanced Clinical Diagnostics KIR Class I 1994-01-03
K935338 LUNG CACINOMA, HUMAN CELLS Advanced Clinical Diagnostics KIR Class I 1994-01-03
K934241 MCCOY CULTURE CELLS-MCCOY Advanced Clinical Diagnostics KIR Class I 1994-01-03
K935336 CYNOMOLOGUS MONKEY KIDNEY CELLS Advanced Clinical Diagnostics KIR Class I 1994-01-03
K935339 HELA HELA EPITHELOID CARCINOMA Advanced Clinical Diagnostics KIR Class I 1994-01-03
K934240 KIDNEY AFRICIAN GREEN MONKEY CELLS-VERO Advanced Clinical Diagnostics KIR Class I 1994-01-03
K934245 HUMAN FORESKIN FIBROBLAST CELLS-H.F.F. Advanced Clinical Diagnostics KIR Class I 1994-01-03
K934246 LUNG DIPLOID HUMAN CELLS-WI-38 Advanced Clinical Diagnostics KIR Class I 1994-01-03
K934242 BUFFALO GREEN MONKEY KIDNEY CELLS-B.G.M.K. Advanced Clinical Diagnostics KIR Class I 1994-01-03
K934239 KIDNEY AFRICAN GREEN MONKEY CELLS-CV-1 Advanced Clinical Diagnostics KIR Class I 1994-01-03
K934497 CBC-STK(TM) HEMATOLOGY CONTROL/MULTIPLE R&D Systems, Inc. JCN Class II 1993-12-06
K934584 SPECTROLYSE FACTOR VII:C Meditech, Inc. GGP Class II 1993-12-06
K934064 REFLOTRON HEMOGLOBIN TEST TABS Boehringer Mannheim Corp. KHG Class II 1993-12-06

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