meddevicedb.com FDA Device Reference

Review Panel

Hematology FDA 510(k) Clearances & Devices

Cleared Devices
4,197
Product Codes (page)
34
Latest Decision
2010-08-23

Clearances · page 5 of 42

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K101335 CELL-CHEX Streck GLQ Class II 2010-08-23
K091303 LIQUICHEK HEMATOLOGY-16 CONTROL LV, MODEL: 295LV Bio-Rad Laboratories JPK Class II 2010-08-02
K090346 ADVIA 2120/2120I BODY FLUIDS Siemens Healthcare Diagnostics GKZ Class II 2010-07-28
K100031 IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10 Ind Diagnostic, Inc. KHE Class II 2010-07-19
K100817 BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST Princeton BioMeditech Corp. KHE Class II 2010-07-01
K083878 LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA R2 Diagnostics, Inc. GIR Class I 2010-06-25
K092987 INRATIO/INRATIO2 TEST STRIPS Biosite Incorporated GJS Class II 2010-06-11
K092116 EASYCELL CELL LOCATOR Medica Corp. JOY Class II 2010-05-12
K100341 SPERMCHECK FERTILITY Princeton BioMeditech Corp. POV Class II 2010-05-04
K093129 ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II Illumina, Inc. NPQ Class II 2010-04-28
K093974 ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FII GENOTYPING Osmetech Molecular Diagnostics NPQ Class II 2010-04-22
K093394 BC-3200 AUTO HEMATOLOGY ANALYZER,M-30D DILUENT, M-30R RINSE, M-30CFL LYSE, M-30E-Z CLEANSER, M-30PROBE CLEANSER, BC-3D C Shenzhen Mindray Bio-Medical Electronics Co., Ltd. GKZ Class II 2010-04-08
K093243 COAGUSENSE SELF-TEST PROTHROMBIN TIME/INR MONITORING SYSTEM Coagusense, Inc. GJS Class II 2010-04-07
K091313 SYSMEX MODEL XT-4000I Sysmex America, Inc. GKZ Class II 2010-03-30
K083842 ROTEM DELTA THROMBOELASTOMETRY SYSTEM Pentapharm GmbH JPA Class II 2010-03-23
K093460 COAGUCHEK XS PRO SYSTEM Roche Diagnostics GJS Class II 2010-03-18
K092940 COAGUCHEK XS PLUS PST SYSTEM Roche Diagnostics Corp. GJS Class II 2010-03-05
K091283 CAPILLARYS NEONAT HB (PN 2006) Sebia GKA Class II 2010-02-22
K090264 HEMOSIL D-DIMER HS 500, CONTROLS Instrumentation Laboratory CO DAP Class II 2010-02-05
K093861 IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLE Iris International, Inc. LKM Class II 2010-02-05
K100050 R & D SYSTEMS XERET HEMATOLOGY CONTROL R&D Systems, Inc. JPK Class II 2010-01-29
K082275 CLOVER A1C/GLYCOSYLATED HEMOGLOBIN MONITOR & BLOOD GLUCOSE MONITOR, MODEL IGM-0023 Infopia Co, Ltd. LCP Class II 2010-01-14
K092330 OC-SENSOR DIANA IFOB TEST Polymedco Cancer Diagnostics, LLC OOX Class II 2010-01-08
K093167 STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER Diagnostica Stago, Inc. JPA Class II 2009-12-22
K092170 STA LIATEST FREE PS Diagnostica Stago, Inc. GGP Class II 2009-12-22
K093001 STA-R EVOLUTION EXPERT SERIES HEMOSTASIS SYSTEM AUTOMATED MULTI-PARAMETRIC ANALYZER Diagnostica Stago, Incorporated JPA Class II 2009-12-18
K091711 S- TEST HEMOGLOBIN ALC (HBA1C), MODEL RC0023 Alfa Wassermann Diagnostic Technologies, Inc. LCP Class II 2009-12-11
K092868 CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127 CellaVision AB JOY Class II 2009-11-20
K091916 INNOVANCE D-DIMER, MODEL OPBP09 Siemens Healthcare Diagnostics DAP Class II 2009-10-29
K091433 R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY CONTROL R&D Systems, Inc. JPK Class II 2009-10-28
K091284 VISUCAL-F FROZEN CALIBRATOR PLASMA AND VISUCON-F FROZEN NORMAL AND ABNORMAL CONTROL PLASMA Affinity Biologicals, Inc. GGN Class II 2009-10-28
K090563 HEMOSIL INR VALIDATE, HEMOSIL ISI CALIBRATE, ISIWEB (SOFTWARE) Instrumentation Laboratory CO GGN Class II 2009-10-09
K091980 ACL TOP 700 LAS Instrumentation Laboratory CO GKP Class II 2009-09-22
K090810 THERMO SCIENTIFIC CYTO-CAL COUNT TUBES Microgenics Corp. GKZ Class II 2009-09-18
K082118 XPERT HEMOSIL FACTOR II & FACTOR V ASSAY Cepheid NPQ Class II 2009-09-18
K082811 URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE ANALYZERS Urit Medical Electronic Co., Ltd. JIO Class II 2009-09-11
K083724 WIENER LAB. URINE STRIP 10 AND 11 Wiener Laboratorios Saic JIO Class II 2009-09-02
K080564 SCANSCOPE XT SYSTEM Aperio Technologies NOT Class II 2009-08-14
K090967 BD MULTITEST 6-COLOR TBNK REAGENT, MODEL 644611 Bd Biosciences GKZ Class II 2009-07-31
K090699 VARIANT II TURBO HBA1C KIT KIT-20 AND WASH/DILUENT SOLUTION SET, MODELS 270-2455, 270-2730 Bio-Rad Laboratories, Inc. LCP Class II 2009-07-27
K083896 DESTINY MAX COAGULATION ANALYZER Trinity Biotech JPA Class II 2009-07-02
K091400 MODIFICATION TO AVIE A1C TEST SYSTEM Mec Dynamics Corp LCP Class II 2009-06-11
K090093 STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEM Stanbio Laboratory GKR Class II 2009-06-10
K090209 HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS Instrumentation Laboratory CO KFF Class II 2009-06-02
K081769 INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5 Siemens Healthcare Diagnostics JBQ Class II 2009-05-28
K090413 A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC Bayer Healthcare, LLC LCP Class II 2009-05-14
K083729 HEMOCLOT QUANTI- V-L, FACTOR V-L CALIBRATOR, BIOPHEN V-L CAL (UNDILUTED), BIOPHEN ACT. PC-R CONTROL PLASMA AND BIOPHEN Aniara Diagnostica, LLC GGW Class II 2009-05-08
K081286 MONOCLONAL RABBIT ANTI HUMAN ESTROGEN RECEPTOR ALPHA ANTIBODY CLONE SP1, MODEL M3634 Dako North America, Inc. MYA Class II 2009-05-08
K072288 PATHFAST D-DIMER Mitsubishi Kagaku Iatron GHH Class II 2009-05-06
K090013 CHEMPAQ XBC ANALYZER Chempaq A/S GKZ Class II 2009-04-21
K082091 TRI T-STAT REAGENT ASSAY (DRIED FORM) MODEL 25107-00 Reametrix, Inc. GKZ Class II 2009-04-15
K090201 UA-CELLULAR FOR IQ Streck JPK Class II 2009-03-27
K082227 MINICAP HEMOGLOBIN(E) KIT, MODEL 2207, 2227 Sebia GKA Class II 2009-03-26
K090508 THE BELMONT BUDDY LITE FLUID WARMER Belmont Instrument Corp. BSB Class II 2009-03-26
K081269 AVIE A1C TEST SYSTEM Mec Dynamics Corp LCP Class II 2009-03-20
K090137 STAK-CHEX PLUS RETICS Streck GLQ Class II 2009-03-18
K083518 ACL ACUSTAR, HEMOSIL ACUSTAR D-DIMER, HEMOSIL ACUSTAR D-DIMER CONTROLS Instrumentation Laboratory CO JPA Class II 2009-03-13
K083926 CD4 COUNT Streck GGL Class II 2009-02-11
K081495 CELL-DYN EMERALD SYSTEM Abbott Laboratories GKZ Class II 2009-02-04
K080910 PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & KITS Bioimagene, Inc. NOT Class II 2009-02-04
K083200 X-CAL Streck KRX Class II 2009-02-03
K082162 COULTER BODY FLUID CONTROL Beckman Coulter, Inc. JPK Class II 2009-02-03
K083420 MEDONIC M SERIES Boule Medical AB GKZ Class II 2009-02-03
K083002 SYSMEX UF-500I AUTOMATED URINE PARTICLE ANALYZER Sysmex America, Inc. LKM Class II 2009-02-03
K083175 BERICHROM HEPARIN UF CALIBRATOR, BERICHROM HEPARIN UF CONTROL 1, AND BERICHROM HEPARIN UF CONTROL 2 Siemens Healthcare Diagnostics JPA Class II 2009-01-26
K083159 BERICHROM HEPARIN LMW CALIBRATOR, BERICHROM HEPARIN LMW CONTROL 1, AND BERICHROM HEPARIN LMW CONTROL 2 Siemens Healthcare Diagnostics JPA Class II 2009-01-26
K081822 COULTER 6C CELL CONTROL, MODELS 628027 & A59925 Beckman Coulter, Inc. JPK Class II 2009-01-21
K081641 COULTER LIN-X LINEARITY CONTROL Beckman Coulter, Inc. JPK Class II 2009-01-16
K081895 ADVIA CHEMISTRY HEMOGLOBIN A1C, ADVIA CHEMISTRY A1C CALIBRATORS Siemens Medical Solutions Diagnostics LCP Class II 2009-01-08
K081930 UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM Beckman Coulter, Inc. GKZ Class II 2008-12-19
K082859 HEMOSIL ROUTINE CONTROL LEVEL 1, LEVEL 2, LEVEL 3 UNASSAYED Instrumentation Laboratory CO GGN Class II 2008-12-19
K082631 THROMBO TEK PSE, MODEL 90-480 R2 Diagnostics, Inc. GGP Class II 2008-12-17
K082248 STA SATELLITE AUTOMATED MULTI-PARAMETER ANALYZER Diagnostica Stago, Inc. JPA Class II 2008-12-12
K080595 CELLAVISION DM96 WITH THE BODY FLUID APPLICATION CellaVision AB JOY Class II 2008-12-05
K082205 FACTOR VIII ANTIBODY SCREEN Genetic Testing Institute GGP Class II 2008-11-20
K080254 SCANSCOPE XT SYSTEM Aperio Technologies OEO Class II 2008-10-31
K081732 INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLS Siemens Healthcare Diagnostics DAP Class II 2008-10-24
K080003 BINAXNOW G6PD TEST Binax, Inc. JBF Class II 2008-10-23
K073309 ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT Horiba Abx LCP Class II 2008-10-17
K082675 STA-R EVOLUTION AUTOMATED MULTI-PARAMETRIC ANALYZER Diagnostica Stago, Inc. JPA Class II 2008-10-10
K081890 SYSMEX XT-SERIES IG PARAMETER,SYSMEX XT-SERIES RET-HE PARAMETER Sysmex America, Inc. GKZ Class II 2008-10-10
K071132 G8 AUTOMATED HPLC ANALYZER, MODEL HLC-723 G8 Tosoh Bioscience, Inc. LCP Class II 2008-09-16
K081610 SYSMEX MODEL XS-1000IC AUTOMATED HEMATOLOGY ANALYZER Sysmex America, Inc. GKZ Class II 2008-08-29
K081526 FLOWCARE TLG REAGENT Beckman Coulter, Inc. GKZ Class II 2008-08-14
K081213 BD FACSCOUNT CD4 REAGENTS WITH MODEL 339010 Bd Biosciences GKZ Class II 2008-08-14
K073677 SCANSCOPE XT SYSTEM Aperio Technologies NQN Class II 2008-08-01
K073042 HEMOSIL D-DIMER Instrumentation Laboratory DAP Class II 2008-07-31
K081719 STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM Stanbio Laboratory GKR Class II 2008-07-18
K080812 HEMOCCULT ICT Beckman Coulter, Inc. KHE Class II 2008-06-25
K080618 DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID Jas Diagnostics, Inc. LCP Class II 2008-05-23
K073377 ACL TOP (WITH SYSTEM SOFTWARE V3.0.0) Instrumentation Laboratory CO GKP Class II 2008-05-04
K080887 SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARE Sysmex America, Inc. LKM Class II 2008-05-02
K080911 VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING SYSTEM AND VARIANT NBS WORKSTATION WITH Bio-Rad Laboratories Inc., Clinical Systems Divisi GKA Class II 2008-05-02
K071867 RAPID GENOTYPING ASSAY -CYP2C9 & VKORC1, MODEL CATALOG NO. 006+0203 GACTGA Paragondx, LLC ODV Class II 2008-04-28
K072714 TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM Roche Diagnostics Corp. LCP Class II 2008-04-18
K072686 AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS Axis-Shield Diagnostics, Ltd. LCP Class II 2008-03-17
K071242 DBEST ONE STEP OCCULT BLOOD TEST KITS Ameritek USA, Inc. KHE Class II 2008-03-06
K080069 DIMERTEST American Diagnostica, Inc. DAP Class II 2008-02-13
K080016 NRBC-CHEX FOR ADVIA Streck GJR Class II 2008-02-05
K072920 HANDHELD BASE UNIT Roche Diagnostics Corp. GJS Class II 2008-01-31

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