meddevicedb.com FDA Device Reference

Review Panel

Hematology FDA 510(k) Clearances & Devices

Cleared Devices
4,197
Product Codes (page)
46
Latest Decision
1990-04-16

Clearances · page 22 of 42

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K900895 COAG-A-MATE - RA4 Organon Teknika Corp. KQJ Class II 1990-04-16
K900684 RDW AND MPV INDICES ON HEMAT 12 Texas Intl. Laboratories, Inc. GKZ Class II 1990-04-16
K900276 EXACT ONE(TM) HEMATOLOGY ANALYZER Exact Science, Inc. GKZ Class II 1990-04-16
K900917 COAG-A-MATE - RA4 Organon Teknika Corp. JPA Class II 1990-04-16
K901233 ORTHO ABNORMAL PROTEIN C CONTROL PLASMA Ortho Diagnostic Systems, Inc. GGC Class II 1990-04-11
K900078 SIMULTEST IMK PLUS(TM) Bd Becton Dickinson Vacutainer Systems Preanalytic GKZ Class II 1990-04-02
K896873 COULTER JT3 Coulter Corp. GKZ Class II 1990-03-30
K900782 HEPARIN CONTROL PLASMA, FOR USE IN APTT Medical Diagnostic Technologies, Inc. GGC Class II 1990-03-27
K900792 RISTOCETIN Medical Diagnostic Technologies, Inc. GHR Class II 1990-03-27
K894947 PLATELIA TOXO IGG KIT Kallestad Diag, A Div. of Erbamont, Inc. LGO Class I 1990-03-23
K896670 TIP TOP(R) DISPENSER CAPS Helena Laboratories GJW Class I 1990-03-23
K896174 PROTEIN S ANTIGEN ROCKET EID KIT, CAT. NO. 5359 Helena Laboratories GGP Class II 1990-03-15
K900398 ORTHOKROME* PROTEIN C Ortho Diagnostic Systems, Inc. GGP Class II 1990-03-15
K900395 ORTHOKROME* FACTOR VIII Ortho Diagnostic Systems, Inc. GGP Class II 1990-03-15
K900400 ORTHOKROME* ANTITHROMBIN Ortho Diagnostic Systems, Inc. JBQ Class II 1990-03-15
K900397 ORTHOKROME* ANTIPLASMIN Ortho Diagnostic Systems, Inc. GGP Class II 1990-03-15
K900399 ORTHOKROME* PLASMINOGEN Ortho Diagnostic Systems, Inc. GGP Class II 1990-03-15
K900396 ORTHOKROME* HEPARIN Ortho Diagnostic Systems, Inc. KFF Class II 1990-03-15
K900593 TECHNICON H*2(TM) SYSTEM Technicon Instruments Corp. GKZ Class II 1990-03-14
K900506 MODIFIED COATRON II AND COATRON JR. Astral Medical Systems JPA Class II 1990-03-12
K900484 RET-CHECK Streck Laboratories, Inc. GJR Class II 1990-03-09
K900906 FACTOR II DEFICIENT PLASMA Sigma Chemical Co. GJT Class II 1990-03-06
K900377 COLLEGE OF AMER PATH. REFER. PREP. FOR FIBRINOGEN Baxter Healthcare Corp JPA Class II 1990-03-06
K900407 FACTOR VII DEFICIENT PLASMA Sigma Chemical Co. GJT Class II 1990-03-06
K900409 FACTOR IX DEFICIENT PLASMA Sigma Chemical Co. GJT Class II 1990-03-06
K900412 FACTOR XII DEFICIENT PLASMA Sigma Chemical Co. GJT Class II 1990-03-06
K900410 FACTOR X DEFICIENT PLASMA Sigma Chemical Co. GJT Class II 1990-03-06
K900406 FACTOR V DEFICIENT PLASMA Sigma Chemical Co. GJT Class II 1990-03-06
K900411 FACTOR XI DEFICIENT PLASMA Sigma Chemical Co. GJT Class II 1990-03-06
K900408 FACTOR VIII DEFICIENT PLASMA Sigma Chemical Co. GJT Class II 1990-03-06
K893852 COULTER CLONE T4 MONOCLONAL ANTIBODY Coulter Immunology GKZ Class II 1990-03-02
K893853 COULTER CLONE T8 MONOCLONAL ANTIBODY Coulter Immunology GKZ Class II 1990-03-02
K894179 COULTER CLONE(R) MY4 MONOCLONAL ANTIBODY Coulter Immunology GKZ Class II 1990-02-12
K895095 AKS II Amoco Technology Co. LNJ Class II 1990-02-09
K897136 PROTEIN C ANTIGEN ROCKET EID METHOD NO. 5357 Helena Laboratories GGP Class II 1990-02-05
K900126 TT AND HNTT BY HEMOCHRON International Technidyne Corp. GJA Class II 1990-02-05
K896846 MADIN-DARBY CANINE KIDNEY CULTURE CELLS Baxter Healthcare Corp KIR Class I 1990-02-01
K900017 REP GLYCO CONTROL NORMAL(3209) AND ABNORMAL(3210) Helena Laboratories JPK Class II 1990-01-29
K900133 FACTOR II DEFICIENT PLASMA Medical Diagnostic Technologies, Inc. GJT Class II 1990-01-25
K896922 RAICHEM TM HEMOGLOBIN REAGENT Reagents Applications, Inc. GKK Class II 1990-01-25
K896474 RESUBMITTED FECATWIN SENSITIVE - FECA-EIA Labsystems, Inc. KHE Class II 1990-01-25
K896921 RAICHEM TM HEMOGLOBIN CALIBRATOR Reagents Applications, Inc. KRZ Class II 1990-01-25
K900019 ROCKET REFERENCE PLASMA, CAT NO. 5188 Helena Laboratories GGN Class II 1990-01-25
K900049 APTT-EA REAGENT, AN ELLAGIC ACID ACTIVATED REAGENT Medical Diagnostic Technologies, Inc. GFO Class II 1990-01-25
K896168 HEMOGLOBIN A2 MICRO COLUMN TEST Bio-Rad JPD Class II 1990-01-18
K897060 CBC-CAL(TM) PLUS HEMATOLOGY CALIBRATOR/MULTIPLE R&D Systems, Inc. KSA Class II 1990-01-02
K895917 CYTO-STAT/COULTER CLONE T4-RD1/T8-FITC MONO ANTI Coulter Immunology GKZ Class II 1989-12-29
K890349 SIMULTEST IMK FOR FACS ANALYZER OR FACSCAN Becton Dickinson Immunocytometry Systems GKZ Class II 1989-12-29
K894949 SQA United Medical Systems, Inc. POV Class II 1989-12-29
K896334 CLP GLYCOSYLATED HEMOGLOBIN CONTROL-ER Creative Laboratory Products, Inc. LCP Class II 1989-12-11
K896335 CLP GLYCOSYLATED HEMOGLOBIN CONTROL-NR Creative Laboratory Products, Inc. LCP Class II 1989-12-11
K896625 THROMBOPLASTIN, FOR USE IN PROTHROMBIN TIME DETER. Medical Diagnostic Technologies, Inc. GJS Class II 1989-12-11
K895661 GLYCOTEST II GLYHB ASSAY KIT Pierce Chemical Co. LCP Class II 1989-12-07
K896545 ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) Sigma Chemical Co. GFO Class II 1989-12-01
K895745 SICKLE CELL SOLUBILITY TEST KIT Simmler, Inc. JBB Class II 1989-11-29
K893393 EPO-TRAC BY RADIOIMMUNOASSAY (RIA) Incstar Corp. GGT Class II 1989-11-21
K896092 ALKALINE PHOSPHATASE, LEUKOCYTE, KIT Sigma Chemical Co. GHD Class I 1989-11-09
K896154 PARA TECH FOR TECHNICON H-1 Streck Laboratories, Inc. JCN Class II 1989-11-09
K896052 FIBRINOGEN ASSAY KIT Medical Diagnostic Technologies, Inc. KQJ Class II 1989-11-09
K895466 AVL MODEL 912 CO-OXYLITE Avl Scientific Corp. GLY Class II 1989-11-06
K896033 FDP COLLECTION TUBES Medical Diagnostic Technologies, Inc. JCO Class II 1989-10-27
K895844 THROMBELASTOGRAPH(R) Haemoscope Corp. GKP Class II 1989-10-24
K894951 MODIFIED HEMOGLOBIN REAGENT SET Macomb Biotechnology, Inc. GKK Class II 1989-10-24
K893453 GLYCABEN Exocell, Inc. LCP Class II 1989-10-23
K894389 CREATININE FOR MANUAL OR AUTOMATED APPLICATIONS Catachem, Inc. GGX Class I 1989-10-12
K895127 ARGOS Abx, Inc. GKZ Class II 1989-10-10
K894943 CLINIGEN ERYTHROPOIETIN HUMAN SERUM CONTROLS 1,2,3 Amgen, Inc. GGT Class II 1989-10-10
K895101 BIOTRACK HEMOGLOBIN TEST CARTRIDGE Biotrack, Inc. KHG Class II 1989-10-10
K895260 ABNORMAL COAGULATION CONTROL PLASMA-1 (ACCP-1) Medical Diagnostic Technologies, Inc. GGC Class II 1989-10-06
K895373 HEMATOLOGY CONTROL Medical Specialties Intl., Inc. JCN Class II 1989-10-06
K895262 NORMAL COAGULATION CONTROL PLASMA (NCCP) Medical Diagnostic Technologies, Inc. GIZ Class II 1989-10-06
K895503 ABNORMAL REFERENCE PLASMA-VIII Medical Diagnostic Technologies, Inc. GJT Class II 1989-10-06
K895255 APTT-P REAGENT, A PARTICLE ACTIVATED REAGENT Medical Diagnostic Technologies, Inc. GFO Class II 1989-10-06
K895261 ABNORMAL COAGULATION CONTROL PLASMA-2 (ACCP-2) Medical Diagnostic Technologies, Inc. GGC Class II 1989-10-06
K895504 ABNORMAL REFERENCE PLASMA-IX Medical Diagnostic Technologies, Inc. GJT Class II 1989-10-06
K894851 TRU-TRAX Humagen, Inc. GIO Class I 1989-09-29
K894539 SYSMEX R-1000 AUTOMATED RETICULOCYTE ANALYZER Toa Medical Electronics USA, Inc. GKL Class II 1989-09-26
K894651 COULTER POSITIVE CONTROL CELLS Coulter Corp. GGL Class II 1989-09-13
K894359 CLOTRAC CITRATED WHOLE BLOOD COAGULATION CONTROLS Hemotec, Inc. JPA Class II 1989-09-05
K894467 THROMBIN TIME REAGENT Sigma Chemical Co. GJA Class II 1989-09-05
K894466 HEPCON(R) CV WHOLE BLOOD COAGULATION CONTROLS Hemotec, Inc. JPA Class II 1989-09-05
K894317 HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS. Hemotec, Inc. JOX Class II 1989-09-05
K893984 HGB-CAL SET/MULTIPLE R&D Systems, Inc. KRZ Class II 1989-08-15
K884605 COULTER CLONE MO2 Coulter Immunology GKZ Class II 1989-08-15
K885114 SALMONELLA IFA* Investigacion Farmaceutica S.A. DE C.V. GHC Class I 1989-08-15
K893985 HGB-CONTROL SET/MULTIPLE R&D Systems, Inc. GGM Class II 1989-08-15
K894425 ACS HUMAN PLASMA COAGULATION CONTROL LEVEL III Analytical Control Systems, Inc. GGC Class II 1989-08-03
K893961 ABBOTT IMX(TM) D-DIMER Abbott Laboratories GHH Class II 1989-08-03
K891276 QBC MALARIA SYSTEM Bd Becton Dickinson Vacutainer Systems Preanalytic GKZ Class II 1989-08-03
K894052 ELECTRA 1000C AUTOMATIC COAGULATION TIMER Medical Laboratory Automation Systems, Inc. GKP Class II 1989-07-27
K893894 CHARISE CHARLES REAGENT BLOOD STRIPS Lee Import Domestic Consulting JIO Class II 1989-07-27
K893970 ACS HUMAN PLASMA COAGULATION CONTROL LEVEL II Analytical Control Systems, Inc. GGC Class II 1989-07-25
K893971 ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL II Analytical Control Systems, Inc. GGC Class II 1989-07-25
K893895 HEMATOLOGY CONTROL MIXTURES FOR QUALITY CONTROL Intercare Diagnostics, Inc. JPK Class II 1989-07-25
K894338 ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL III Analytical Control Systems, Inc. GGC Class II 1989-07-25
K894045 MODIFIED POLYCHROME IV STAIN Devetec, Inc. KFD Class I 1989-07-25
K893562 A.QC HCT LEVEL 1 AND 2 Johnson & Johnson Professionals, Inc. GLK Class II 1989-07-14
K893536 FACTOR XI DEFICIENT PLASMA Medical Diagnostic Technologies, Inc. GJT Class II 1989-06-23
K893523 FACTOR X DEFICIENT PLASMA Medical Diagnostic Technologies, Inc. GJT Class II 1989-06-23
K893524 FACTOR IX DEFICIENT PLASMA Medical Diagnostic Technologies, Inc. GJT Class II 1989-06-23

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