meddevicedb.com FDA Device Reference

Review Panel

Hematology FDA 510(k) Clearances & Devices

Cleared Devices
4,197
Product Codes (page)
40
Latest Decision
1989-06-23

Clearances · page 23 of 42

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K893608 ACTICHROME ATIII KIT American Diagnostic Corp. JBQ Class II 1989-06-23
K892859 THE STAGO VIII DEFICIENT PLASMA KIT American Bioproducts Co. GGP Class II 1989-06-23
K893534 FACTOR XII DEFICIENT PLASMA Medical Diagnostic Technologies, Inc. GJT Class II 1989-06-23
K893533 FACTOR V DEFICIENT PLASMA Medical Diagnostic Technologies, Inc. GJT Class II 1989-06-23
K893525 FACTOR VIII DEFICIENT PLASMA Medical Diagnostic Technologies, Inc. GJT Class II 1989-06-23
K893787 LIFECELL RECOVERY CONTAINER Baxter Healthcare Corp KJF Class I 1989-06-23
K893535 FACTOR VII DEFICIENT PLASMA Medical Diagnostic Technologies, Inc. GJT Class II 1989-06-23
K893783 ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL I Analytical Control Systems, Inc. GIZ Class II 1989-06-23
K885107 THROMBOSTIN IFA* Investigacion Farmaceutica S.A. DE C.V. GJS Class II 1989-06-23
K893784 ACS HUMAN PLASMA COAGULATION CONTROL LEVEL I Analytical Control Systems, Inc. GIZ Class II 1989-06-23
K893650 PLATELET AGGREGATION PROFILER MODEL PAP-4C Bio/Data Corp. JPA Class II 1989-06-23
K893378 PROTHROMBIN TIME (PT) BY HEMOCHRON International Technidyne Corp. GJS Class II 1989-06-22
K892209 APTT BY HEMOCHRON(R) Intensive Technology, Inc. GFO Class II 1989-06-22
K893224 REP GLYCO-8 KIT, #3208/REP GLYCO-16 KIT, #3207 Helena Laboratories LCP Class II 1989-06-20
K893423 QBC III CENTRIFUGAL HEMATOLOGY SYSTEM Bd Becton Dickinson Vacutainer Systems Preanalytic GKZ Class II 1989-06-20
K891235 PRIMUS MODEL CLC 330 Primus, Inc. LCP Class II 1989-06-16
K892205 DANAM VECTOR-8+ Danam Electronics GKZ Class II 1989-06-13
K893663 INSTANT EOSIN-AQUEOUS Shandon, Inc. HYB Class I 1989-06-13
K892645 AMICON VITAFIBER FLO-PATH BIORECT/VLS CELL CULT SY Amicon, Inc. KJF Class I 1989-06-13
K893530 IRISTAIN FORMULA 2, PARTS 1 AND 2 Intl. Remote Imaging Systems JTS Class I 1989-06-13
K892050 HELENA THROMBOPLASTIN REAGENT Helena Laboratories GJS Class II 1989-06-07
K891407 LEUCOPREP CELL SEPARATION TUBE Bd Becton Dickinson Vacutainer Systems Preanalytic JCF Class I 1989-05-26
K892522 SR30/SR50/SR60 AUTO SEDIMENT RATE SYSTEM, MODIFIED Gespac, Inc. GKB Class I 1989-05-24
K892658 SDI PREPAX COUNTAPETTE KIT Scientific Distributors, Inc. JCG Class I 1989-05-24
K891015 COAG-1 APTT TEST CARD Cardiovascular Diagnostic Services GFO Class II 1989-05-22
K892938 AMNIO-GROW TM Inovar Biologicals, Inc. KIT Class I 1989-05-22
K892241 FETAL HEMOGLOBIN Sure-Tech Diagnostic Associates, Inc. GHQ Class II 1989-05-17
K884266 PH BLOOD GAS CONTROL PRODUCTS Alko Diagnostic Corp. JPK Class II 1989-05-16
K890859 EDL GLOBAL ACTIVATED PARTIAL THROMBOPLASTIN TIME Elite Diagnostic , Ltd. GFO Class II 1989-04-21
K890633 ENZYGNOST PLATELET FACTOR 4 (PF4) KIT Behring Diagnostics, Inc. LCO Class II 1989-04-21
K884797 BERICHROM ALPHA-2-ANTIPLASMIN Behring Diagnostics, Inc. GGP Class II 1989-04-21
K891370 EDL ONE-STAGE PROTHROMBIN TIME REAGENT Elite Diagnostic , Ltd. GJS Class II 1989-04-21
K890634 BERICHROM PROTEIN C KIT Behring Diagnostics, Inc. GGP Class II 1989-04-21
K891337 THROMBOSCREEN APTT REAGENT Pacific Hemostasis GFO Class II 1989-04-21
K890491 CELL-DYN 3000 MULTI-PARAMETER HEMATOLOGY ANALYER Abbott Diagnostics GKZ Class II 1989-04-18
K884206 HEMAWIPE SYSTEM, THE CIVILIZED TEST Labeltape Meditect, Inc. KHE Class II 1989-04-18
K891907 QBC(R) CENTRIFUGAL HEMATOLOGY CONTR/MULTI MODIFIED R&D Systems, Inc. JCN Class II 1989-04-11
K891175 EDL ABNORMAL COAGULATION CONTROL Elite Diagnostic , Ltd. GGL Class II 1989-04-10
K891169 DADE THROMBOPLASTIN IS Baxter Healthcare Corp GJS Class II 1989-04-10
K891179 EDL NORMAL COAGULATION CONTROL Elite Diagnostic , Ltd. GIZ Class II 1989-04-10
K884184 SIGMA PROCEDURE NO. 465 FOR DETER. OF FRUCTOSAMINE Sigma Diagnostics, Inc. LCP Class II 1989-03-28
K890422 ABBOTT TESTPACK(TM) D-DIMER Abbott Laboratories GHH Class II 1989-03-27
K890861 ATS DOBELL & O'CONNOR'S IODINE Alpha-Tec Systems, Inc. JTS Class I 1989-03-23
K890767 NE-CHECK Streck Laboratories, Inc. JPK Class II 1989-03-23
K890849 HEMATASTAT H-70 Separation Technology, Inc. GKG Class II 1989-03-21
K890619 EDL ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT Elite Diagnostic , Ltd. GFO Class II 1989-03-15
K884940 RELLPLATE C KIT, RELLPLATE C BULK PLATES American Diagnostic Corp. GGP Class II 1989-03-13
K884941 ACTICLOT C KIT American Diagnostic Corp. GGP Class II 1989-03-13
K890189 AGEN DIMERTEST EIA Agen Biomedical , Ltd. DAP Class II 1989-03-03
K890409 DADE(R) PLASMINOGEN CHROMOGENIC ASSAY Baxter Healthcare Corp GGP Class II 1989-02-27
K890749 CBC-TECH (TM) HEMATOLOGY CONTROL/MULTIPLE R&D Systems, Inc. JPK Class II 1989-02-27
K890052 BIOTRACK APTT REAGENT CARTRIDGE Biotrack, Inc. GFO Class II 1989-02-24
K890700 MELANOCYTE GROWTH MEDIUM (MGM) Clonetics Corp. KIT Class I 1989-02-24
K890701 ENDOTHELIAL GROWTH MEDIUM (EGM) Clonetics Corp. KIT Class I 1989-02-24
K890673 WRIGHT-GLEMSA STAIN Sigma Diagnostics, Inc. IAF Class I 1989-02-24
K890674 ACCUSTAIN(TM) - AUTOMATED WRIGHT GIEMSA STAIN SET Sigma Diagnostics, Inc. IAF Class I 1989-02-24
K890020 ATS LUGOL'S IODINE SOLUTION Alpha-Tec Systems, Inc. JTS Class I 1989-02-24
K885227 CLINISTAT HEMOGLOBIN REAGENT TEST Heraeus Kulzer, Inc. KHG Class II 1989-02-24
K890051 BIOTRACK APTT CONTROLS Biotrack, Inc. GIT Class II 1989-02-23
K885332 COULTER FLOW RETICULOCYTE REAGENT Coulter Electronics, Inc. GKL Class II 1989-02-22
K885324 HEMA(PRO)TEC(TION) Medical Products Search, Inc. GIO Class I 1989-02-17
K885028 COULTER 5P CONTROL Coulter Electronics, Inc. GKZ Class II 1989-02-16
K881765 CTS-3060 AUTOMATED SEMEN ANALYZER Motion Analysis Corp. POV Class II 1989-02-15
K890542 MULTIWELL CULTURE PLATE INSERTS Bd Becton Dickinson Vacutainer Systems Preanalytic KIZ Class I 1989-02-14
K890503 SR30/SR50/SR60 AUTOMATED SEDIMENTATION RATE Gespac, Inc. GKB Class I 1989-02-10
K890482 ABC, ABC-1X, ABC(TM) Cell Ent., Inc. KIT Class I 1989-02-10
K890399 MODIFIED D-DI-TEST KIT American Bioproducts Co. GHH Class II 1989-02-07
K885138 CAPILLARY TUBE, BLOOD COLLECTION Coeur Laboratories, Inc. GIO Class I 1989-02-07
K884863 ELECTRA 900C AUTOMATIC COAGULATION TIMER Medical Laboratory Automation Systems, Inc. GKP Class II 1989-02-03
K883710 COULTER CLONE T3 MONOCLONAL ANTIBODY Coulter Immunology GKZ Class II 1989-02-03
K883753 COULTER CLONE T1 MONOCLONAL ANTIBODY Coulter Immunology GKZ Class II 1989-02-03
K884020 COULTER CLONE B4 MONOCLONAL ANTIBODY Coulter Immunology GKZ Class II 1989-02-03
K885035 KOAGULAB* 32-S COAGULATION SYSTEM Ortho Diagnostic Systems, Inc. GKP Class II 1989-02-03
K884881 DADE PROTEIN C CHROMOGENIC ASSAY Baxter Healthcare Corp GGP Class II 1989-02-02
K884901 DADE(R) PROTOTROL SYNTHETIC SUBSTRATE ASSAY CONTRO Baxter Healthcare Corp GGN Class II 1989-02-02
K884856 APTT REAGENT Precision Biologicals, Inc. GFO Class II 1989-01-30
K884855 THROMBOPLASTIN Precision Biologicals, Inc. GJS Class II 1989-01-30
K884854 COAGULATION CONTROL PLASMA (NORMAL & ABNORMAL) Precision Biologicals, Inc. GGN Class II 1989-01-30
K884702 EASY-TEST PARTIAL THROMBOPLASTIN TIME PTT #16629 Em Diagnostic Systems, Inc. GFO Class II 1989-01-27
K884534 PALL HEPCHEK (TM) HEPARIN ABSORPTION FILTER Pall Biomedical Products Co. JPA Class II 1989-01-24
K884618 NOVA CELLTRAK 11 AUTO. HEMA. ANALYZER, CALIBRATORS Nova Biomedical Corp. GKL Class II 1989-01-24
K890148 ATS TB RAPID STAIN SET PRODUCT #034-45 Alpha-Tec Systems, Inc. ICL Class I 1989-01-24
K884590 HEPCON/SYSTEM B-10 HEPARIN ASSAY/SCREEN/CARTRIDGES Hemotec, Inc. KFF Class II 1989-01-10
K884551 DADE FACTOR IX CHROMOGENIC ASSAY Baxter Healthcare Corp GGP Class II 1988-12-30
K885076 COAG-A-MATE XC/XC PLUS VERSION D.00 SOFTWARE Organon Teknika Corp. JPA Class II 1988-12-30
K884544 DADE FACTOR VIII CHROMOGENIC ASSAY Baxter Healthcare Corp GGP Class II 1988-12-30
K884385 FIBRI-PREST/THROMBIN-PREST CONTROLS American Bioproducts Co. GJA Class II 1988-12-28
K884485 KD ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT King Diagnostics, Inc. GFO Class II 1988-12-28
K885132 FACSMATE SAMPLE HANDLING DEVICE Bd Becton Dickinson Vacutainer Systems Preanalytic GKL Class II 1988-12-28
K884384 THROMBIN-PREST REAGENT KIT American Bioproducts Co. GJA Class II 1988-12-28
K885121 CELL SCRAPER Bd Becton Dickinson Vacutainer Systems Preanalytic KJA Class I 1988-12-28
K885093 COULTER STKS Coulter Electronics, Inc. GKZ Class II 1988-12-28
K884315 LABILE LYSING REAGENT Helena Laboratories LCP Class II 1988-12-27
K884471 KVM BLOOD CELL COUNTER Kvm Instruments, Inc. GKL Class II 1988-12-27
K884346 CYTO-STAT/COULTER CLONE T11-RD1/B1-FITC MONO. ANTI Coulter Immunology GKZ Class II 1988-12-27
K882686 ERYTHROPOIETIN ENZYME IMMUNOASSAY Amgen, Inc. GGT Class II 1988-12-20
K884179 TURBOX FIBRINOGEN Unipath , Ltd. KQJ Class II 1988-12-20
K884144 TURBOX ANTITHROMBIN III Unipath , Ltd. JBQ Class II 1988-12-20
K884058 COATEST PROTEIN C Kabivitrum, Inc. GGP Class II 1988-12-13
K883997 SYSMEX NE-8000 Toa Medical Electronics USA, Inc. GKZ Class II 1988-12-05

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