meddevicedb.com FDA Device Reference

Review Panel

Hematology FDA 510(k) Clearances & Devices

Cleared Devices
4,197
Product Codes (page)
40
Latest Decision
1992-06-19

Clearances · page 20 of 42

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K914848 CD4 MONOCLONAL ANTIBODIES Gen Trak, Inc. GKZ Class II 1992-06-19
K914846 CD2 MONOCLONAL ANTIBODIES Gen Trak, Inc. GKZ Class II 1992-06-19
K913320 MIL CM-II COAGULATION MACHINE Medical Innovations Corp. GKN Class II 1992-06-16
K921665 AVK CONTROL I & II American Bioproducts Co. GGC Class II 1992-06-09
K920976 BACTIDROP INDIA INK Remel Co. JTS Class I 1992-06-09
K922021 UNICALIBRATOR KIT American Bioproducts Co. GIZ Class II 1992-06-09
K921344 THROMBO-CALIBRATOR KIT American Bioproducts Co. GGN Class II 1992-06-09
K921363 CASCADE 480 Helena Laboratories GKP Class II 1992-06-09
K920975 BACTIDROP CALCOFLUOR WHITE Remel Co. JTS Class I 1992-06-09
K921684 PTT-LA TEST KIT American Bioproducts Co. GGW Class II 1992-06-09
K921305 GLYCO-TEK AFFINITY COLUMN KIT Helena Laboratories LCP Class II 1992-06-09
K920207 HERMLE Z230H Labnet Intl., Inc. GKG Class II 1992-06-09
K920970 BACTIDROP KOH (10%) Remel Co. JTS Class I 1992-06-09
K920895 DADE(R) PROTHROMBIN FRAGMENT F1.2 ELISA Baxter Diagnostics, Inc. MIF Class II 1992-06-04
K920997 CD-CHEX Streck Laboratories, Inc. GGL Class II 1992-05-31
K920949 SOFTWARE MODIFICATION FOR MILES H*1 S/W VER. 1.5 Heraeus Kulzer, Inc. GKZ Class II 1992-05-15
K915411 DADE IMMUNOADSORBED FACTOR IX DEFICIENT PLASMA Baxter Diagnostics, Inc. GJT Class II 1992-05-11
K914256 YELLOW IRIS URINALYSIS WRKSTA W/IRISCOPE BDY FLU Intl. Remote Imaging Systems GKL Class II 1992-05-01
K920147 THROMBIN CLOTTING TIME REAGENT Helena Laboratories GJA Class II 1992-05-01
K920544 SYSMEX HEMATOLOGY SYSTEM ACCESSORIES Toa Medical Electronics USA, Inc. GKZ Class II 1992-04-29
K920759 CRITSPIN MICRO-HEMATOCRIT Stat-Spin Technologies GKG Class II 1992-04-29
K920981 RISTOCETIN COFACTOR ASSAY/VON WILLEBRAND FACT ASSA Medical Diagnostic Technologies, Inc. GGP Class II 1992-04-17
K915825 MARATHON 6K GENERAL-PURPOSE CENTRIFUGE Fisher Scientific Co., LLC GKF Class II 1992-03-11
K914949 COAGULATION ARPR,CAT.NO.5185 Helena Laboratories GGN Class II 1992-03-04
K915462 FIBRINOGEN CONTROL Sigma Diagnostics, Inc. GIL Class II 1992-03-04
K915418 ELLAGIC ACID APTT REAGENT Helena Laboratories GFO Class II 1992-02-14
K915746 SIMPLASTIN L Organon Teknika Corp. GJS Class II 1992-02-12
K915344 HEMOCHRON ONESTEP APTT TEST International Technidyne Corp. GFO Class II 1992-02-11
K913192 SIMULTEST(TM) IMK-LYMPHOCYTE Bd Becton Dickinson Vacutainer Systems Preanalytic GKZ Class II 1992-02-06
K915203 D-DIMER WELLCOTEST (HA10) Wellcome Diagnostics DAP Class II 1992-01-31
K913622 HEMOPLUS Sarstedt, Inc. KHE Class II 1992-01-31
K915503 FIBRINOGEN FDP CONTROL Cala Diagnostics DAP Class II 1992-01-30
K915463 ACTIVATED PARTIAL THROMBOPLASTIN TIME Sigma Diagnostics, Inc. GGW Class II 1992-01-23
K915071 DIFFERENTIAL COUNTING BOARD Biovation, Inc. GKZ Class II 1992-01-17
K914818 DADE(R) ALPHA 2 ANTIPLASMIN(2 2-AP) CHROMO ASSAY Baxter Diagnostics, Inc. GGP Class II 1992-01-15
K914946 CASCADE 480(TM) AUTO COAG ANALYZER, MODIFICATION Helena Laboratories GKP Class II 1992-01-13
K915441 MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGE Fisher Scientific Co., LLC GKF Class II 1992-01-08
K915163 PROTEIN S EID KIT AND PROTEIN S EID BULK PLATES Biopool AB GGP Class II 1992-01-06
K915083 COAMATE(R) ANTITHROMBIN CHROMOGENIC ASSAY Kabi Pharmacia, Inc. JBQ Class II 1992-01-03
K913667 ANTITHROMBIN III IMMUNOLOGICAL NL TEST KIT The Binding Site, Ltd. JBQ Class II 1992-01-03
K914744 SYSMEX NE-1500, MODIFICATION Toa Medical Electronics USA, Inc. GKZ Class II 1991-12-30
K914099 GAS TRAK CONNECT BLOOD GAS CONTROL Biochemical Sciences, Inc. JPK Class II 1991-12-18
K913384 COLUMNMATE(TM) BETA-THAL CAT. NO. 4515 Helena Laboratories JPD Class II 1991-12-17
K914307 SPECTROLYSE PROTEIN C KIT Biopool AB GGP Class II 1991-12-09
K914014 FACSTRAK FLOW CYTOMETER Bd Becton Dickinson Vacutainer Systems Preanalytic GKZ Class II 1991-12-04
K913249 ACS ULTRA-1 THROMBOPLASTIN Analytical Control Systems, Inc. GJS Class II 1991-12-04
K913614 FRUCTOSAMINE ABG21 TEST SYSTEM Boehringer Mannheim Corp. LCP Class II 1991-12-02
K910481 EPO-RIA Ramco Laboratories, Inc. GGT Class II 1991-11-29
K913250 ACS ULTRA-2 THROMBOPLASTIN Analytical Control Systems, Inc. GJS Class II 1991-11-27
K913879 CBC-8K(TM) HEMATOLOGY CONTROL/MULTIPLE R&D Systems, Inc. JPK Class II 1991-11-27
K913305 CELL-DYN 3000A MULTI-PARAMETER AUTO HEMA ANALZYER Unipath , Ltd. GKZ Class II 1991-11-22
K913427 SICKLE HEMOGLOBIN (HBA/S) CONTROL SET Creative Laboratory Products, Inc. JCM Class II 1991-11-19
K901187 MONOCLONAL ANTIBODY ANTI-CD2 Sigma Chemical Co. GKZ Class II 1991-10-31
K901189 MONOCLONAL ANTIBODY ANTI-CD3 Sigma Chemical Co. GKZ Class II 1991-10-31
K910473 CYTO-STAT(R)/COULTER CLONE(R) T11-RD1/B4-FITC Coulter Immunology GKZ Class II 1991-10-31
K911434 THROMBONOSTIKA F1.2 Organon Teknika Corp. MIF Class II 1991-10-31
K912085 ACLAIMS-IS W-Technology LNJ Class II 1991-10-31
K901186 MONOCLONAL ANTIBODY ANTI-CD19 Sigma Chemical Co. GKZ Class II 1991-10-31
K901188 MONOCLONAL ANTIBODY ANTI-CD5 Sigma Chemical Co. GKZ Class II 1991-10-31
K912748 BINAX EQUATE(R) GLYCOHEMOGLOBIN 3 MINUTE TEST KIT Binax, Inc. LCP Class II 1991-10-31
K913861 HEMOCHRON(R) KACT International Technidyne Corp. JBP Class II 1991-10-18
K911981 HEMOCARD HEMOGLOBIN S Isolab, Inc. GHM Class II 1991-10-09
K912876 FIBRINOSTIKA FBDP MICROELISA SYSTEM Organon Teknika Corp. DAP Class II 1991-10-09
K912711 IL TEST PROCLOT ASSAY STYSTEM Instrumentation Laboratory CO GGP Class II 1991-10-09
K913061 FIBRINOGEN DETERMINATION KIT Sigma Diagnostics, Inc. GIS Class II 1991-10-09
K913424 STACLOT(R) PROTEIN S TEST KIT American Bioproducts Co. GGP Class II 1991-10-08
K913259 NOVA CELLTRAK 12 AUTO MULTI-PARA HEMA ANALYZER/CAL Nova Biomedical Corp. GKZ Class II 1991-10-08
K912979 HEMAWIPE SYSTEM, THE CIVILIZED TEST, MODIFICATION Labeltape Meditect, Inc. KHE Class II 1991-10-04
K912468 LIATEST PROTEIN S KIT American Bioproducts Co. GGP Class II 1991-10-02
K905709 BECKMAN DIATRAC HEMOGLOBIN A ELECTROPHORESIS KIT Beckman Instruments, Inc. LCP Class II 1991-09-23
K913128 HEMATASTAT C-70B Separation Technology, Inc. GKG Class II 1991-09-23
K912087 ACL COAGULATION SYSTEMS,MODELS 1000,2000,3000,PLUS Instrumentation Laboratory CO JPA Class II 1991-09-19
K913005 BACTIDROP(TM) LACTOPHENOL ANILINE BLUE Remel Co. JIO Class II 1991-09-16
K911626 SYSTEM 9000, INTERPRETIVE DIFF CELL COUNTER Serono Baker Diagnostics System GKZ Class II 1991-09-13
K912494 SYSMEX(TM) R-3000 AUTOMATED RETICULOCYTE ANALYZER Toa Medical Electronics USA, Inc. GKL Class II 1991-09-10
K912679 DADE(R) IMMUNOADSORBED FACT V DEF PLASMA (HUMAN) Baxter Healthcare Corp GJT Class II 1991-09-10
K911625 AMES DCA 2000TM ANALYZER AND REAGENT SYSTEM Heraeus Kulzer, Inc. LCP Class II 1991-09-05
K911777 ROCKET REFERENCE PLASMA, CAT. NO. 5188, MODIFIED Helena Laboratories GGN Class II 1991-08-22
K912025 SPECTROLYSE PLASMINOGEN SK KIT Biopool AB GGP Class II 1991-08-22
K912774 ARACHIDONIC ACID Helena Laboratories JBX Class II 1991-08-22
K912201 PACKS-4 (TM) ANALYZER Helena Laboratories JBY Class II 1991-08-16
K912102 ACS LIQUID THROMBOPLASTIN Analytical Control Systems, Inc. GJS Class II 1991-08-09
K911745 SIMPLATE PEDIATRIC Organon Teknika Corp. JCA Class II 1991-08-09
K910849 SYSMEX F-810 Toa Medical Electronics USA, Inc. GKL Class II 1991-07-26
K911173 SYSMEX F-310 Toa Medical Electronics USA, Inc. GKL Class II 1991-07-26
K911172 SYSMEX F-610 Toa Medical Electronics USA, Inc. GKL Class II 1991-07-26
K912061 HEPARIN ADSORBENT Sigma Diagnostics, Inc. JPA Class II 1991-07-24
K912133 PX COULTER(R) CELL CONTROL Coulter Electronics, Inc. JPK Class II 1991-07-17
K911240 HEPCON HMS WITH BODY SURFACE AREA CALCULATION Hemotech, Inc. JOX Class II 1991-07-17
K911996 SURGICUTT-BLEEDING TIME DEVICE, MODIFICATION International Technidyne Corp. JCA Class II 1991-07-17
K911994 HEMOCHRON(R) APTT, MODIFICATION International Technidyne Corp. GFO Class II 1991-07-17
K911995 PROTHROMBIN TIME (PT) BY HEMOCHRON, MODIFICATION International Technidyne Corp. GJS Class II 1991-07-17
K910745 HEMOGLOBIN REAGENT Toa Medical Electronics USA, Inc. GKR Class II 1991-07-11
K911793 COULTERCLONE Coulter Immunology GKZ Class II 1991-07-09
K910827 ABL520 BLOOD GAS SYSTEM Radiometer America, Inc. GHS Class II 1991-07-09
K912357 3K-CAL HEMATOLOGY CALIBRATOR/MULTIPLE R&D Systems, Inc. KRX Class II 1991-07-09
K911075 COLOSCREEN Helena Laboratories KHE Class II 1991-07-03
K905798 COLOCARE Helena Laboratories KHE Class II 1991-07-03
K911385 COULTER(R) MH010 Coulter Electronics, Inc. GKZ Class II 1991-06-17
K911885 DADE(R) PROTEIN C ABNORMAL CONTRAL Baxter Healthcare Corp GGC Class II 1991-06-11

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