meddevicedb.com FDA Device Reference

Review Panel

Hematology FDA 510(k) Clearances & Devices

Cleared Devices
4,197
Product Codes (page)
37
Latest Decision
2004-11-17

Clearances · page 8 of 42

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K042459 SYNCHRON LX SYSTEMS HEMOGLOBIN A1C2 (HBA1C2) REAGENT Beckman Coulter, Inc. LCP Class II 2004-11-17
K042836 LIQUICHEK RETICULOCYTE CONTROL (A) Bio-Rad JPK Class II 2004-11-05
K042724 MODIFICATION TO COULTER LH 500 HEMATOLOGY ANALYZER Beckman Coulter, Inc. GKZ Class II 2004-10-29
K042750 QC-BEADS Bioscreen, Inc. NRF Class II 2004-10-29
K042193 DIAZYME GLYCATED SERUM PROTEIN ENZYMATIC ASSAY KIT Diazyme Laboratories LCP Class II 2004-10-29
K041408 POLYMEDCO OC AUTO MICRO 80 FOB TEST Polymedco, Inc. OOX Class II 2004-10-21
K042209 CONTROL PLASMA N AND CONTROL PLASMA P Dade Behring, Inc. GGN Class II 2004-10-21
K042587 RETIC-CHEX FOR CELL-DYN Streck Laboratories, Inc. JPK Class II 2004-10-19
K042206 PURPLE/BLACK HEPARIN ASSAY CONTROL Medtronic Vascular GGN Class II 2004-10-18
K042175 HEPARINASE HR ACT CONTROL, MODEL 550-12 Medtronic Vascular GGN Class II 2004-10-18
K031296 LIQUI-HEME GLYCO A1C ASSAY Biodiagnostic Intl LCP Class II 2004-10-15
K042336 METER TRAX TRILEVEL, LOW LEVEL, MID LEVEL, HIGH LEVEL TRILEVEL MINIPAK Bio-Rad Laboratories, Inc. JPK Class II 2004-10-14
K042173 COULTER A T 5DIFF CAP PIERCE (CP) Beckman Coulter, Inc. GKZ Class II 2004-10-12
K042423 VERIFYNOW-ASPIRIN ASSAY Accumetrics, Inc. JOZ Class II 2004-10-06
K042070 HEPARIN DOSE RESPONSE CARTRIDGE, MODEL 304-20 Medtronic Vascular JOX Class II 2004-10-01
K041074 BD FACSCANTO WITH BD FACSANTO SOFTWARE Bd Biosciences GKZ Class II 2004-09-17
K042251 BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM Bayer Healthcare, LLC GKZ Class II 2004-09-17
K040591 DUET SYSTEM Bioview , Ltd. JOY Class II 2004-09-16
K040725 BD FACSCANTO SYSTEM Becton Dickinson Immunocytometry Systems GKZ Class II 2004-09-10
K040026 BD FACS 7-COLOR SETUP BEADS Becton Dickinson Immunocytometry Systems GKZ Class II 2004-09-10
K041764 THE VITROS 5,1 FS CHEMISTRY SYSTEM Ortho-Clinical Diagnostics LCP Class II 2004-09-09
K033491 ROCHE DIAGNOSTICS CARDIAC D-DIMER RAPID ASSAY; ROCHE DIAGNOSTICS CARDIAC D-DIMER CONTROLS Roche Diagnostics Corp. DAP Class II 2004-09-01
K042094 R&D CBC-XE HEMATOLOGY CONTROL R&D Systems, Inc. JPK Class II 2004-09-01
K041502 THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY Haemoscope Corp. JOZ Class II 2004-09-01
K040703 URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS Dirui Industrial Co., Ltd. JIO Class II 2004-08-26
K041635 G5 I HBA1C TEST, G5 II HBA1C TEST Provalis Diagnostics , Ltd. LCP Class II 2004-08-16
K041202 HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST W.H.P.M., Inc. KHE Class II 2004-08-12
K041297 POLYMEDCO OC LIGHT FOBT TEST Polymedco, Inc. KHE Class II 2004-08-12
K041438 ADVANCED D-DIMER ASSAY Dade Behring, Inc. DAP Class II 2004-08-11
K041600 QWIKCHECK-BEADS Medical Electronics Systems , Ltd. NRF Class II 2004-07-27
K041039 FERTELL MALE FERTILITY TEST Genosis , Ltd. POV Class II 2004-07-20
K040362 DIAPHARMA FACTOR X KIT Diapharma Group, Inc. GJT Class II 2004-07-12
K041457 LIQUICHEK HEMATOLOGY CONTROL (A) Bio-Rad JPK Class II 2004-06-28
K040898 CELLSEARCH EPITHELIAL CELL CONTROL KIT Veridex, LLC NRS Class II 2004-06-28
K040437 TRIAGE PROFILER S.O.B. PANEL Biosite Incorporated DAP Class II 2004-06-25
K040987 CRYOCHECK CLOT C Precision Biologic, Inc. GGP Class II 2004-06-18
K041234 HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM Hemocue, Inc. GKR Class II 2004-06-10
K040882 VIDAS D-DIMER EXCLUSION ASSAY, MODEL 30 442 bioMerieux, Inc. DAP Class II 2004-06-10
K041130 CDS HEMATOLOGY CALIBRATOR (CDS CAL) Clinical Diagnostic Solutions, Inc. KRZ Class II 2004-06-10
K041444 BIO-RAD D-10 DUAL PROGRAM Bio-Rad Laboratories, Inc. LCP Class II 2004-06-09
K041240 SEMEN ANALYSIS QUALITY CONTROL, ASSAYED AND UNASSAYED Fertility Solutions, Inc. NRF Class II 2004-06-02
K040293 HEALTHTEST HEPARIN/PLATELET FACTOR 4 ANTIBODY ASSAY Akers Laboratories, Inc. LCO Class II 2004-05-28
K040296 PHOSPHOPLASTIN RL R2 Diagnostics, Inc. GJS Class II 2004-05-24
K040146 INTERLAB ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM Interlab S.R.L. GKA Class II 2004-05-04
K040843 HEMOSIL VON WILLEBRAND ACTIVITY Instrumentation Laboratory CO GGP Class II 2004-04-30
K040872 VARIANT II HEMOGLOBIN A1C Bio-Rad Laboratories, Inc. LCP Class II 2004-04-15
K032139 REAADS VON WILLEBRAND FACTOR ACTIVITY TEST KIT, MODEL 10826 Corgenix, Inc. GGP Class II 2004-04-05
K032951 CHRONO-LOG WHOLE BLOOD AGGREGOMETER, MODELS 591A AND 592A Chrono-Log Corp. JOZ Class II 2004-04-02
K040359 HEMOSIL SPECIAL TEST CONTROLS LEVEL 1 & 2 Instrumentation Laboratory CO JPA Class II 2004-03-19
K033200 ARIOL Applied Imaging Corp. NQN Class II 2004-03-18
K040073 SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XE-2100 SERIES (XE-2100, XE-2100L) Sysmex America, Inc. GKZ Class II 2004-03-18
K040077 IMMUNICON CELLTRACKS AUTOPREP SYSTEM Immunicon Corp. GKH Class I 2004-03-12
K040275 LYPHOCHEK HEMOSTASIS CONTROL Bio-Rad GGN Class II 2004-02-27
K034007 HEMOSIL FACTOR VIII DEFICIENT PLASMA Instrumentation Laboratory CO GJT Class II 2004-02-13
K032677 SYSMEX POCH-100I Sysmex America, Inc. GKL Class II 2004-02-11
K033840 CELLAVISION DM96 AUTOMATIC HEMATOLOGY ANALYZER CellaVision AB JOY Class II 2004-02-10
K033674 MULTIGENT HEMOGLOBIN A1C (REAGENTS), HB A1C CALIBRATORS AND HB A1C CONTROLS Seradyn, Inc. LCP Class II 2004-02-09
K031363 QCA (VERSION 3.1) Cell Analysis, Inc. NQN Class II 2004-02-05
K033471 PHOSPHOLIN ES AND CALCIUM CHLORIDE R2 Diagnostics, Inc. GGW Class II 2004-02-04
K032862 INTERLAB ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM Interlab S.R.L. JBD Class II 2004-02-03
K032214 MEDONIC CA620/530 HEMATOLOGY ANALYZER Boule Medical AB GKZ Class II 2004-01-29
K033414 ACL TOP MODEL, TOP Instrumentation Laboratory CO GKP Class II 2004-01-12
K031715 ARIOL HER-2/NEU IHC Applied Imaging Corp. NOT Class II 2004-01-08
K033775 HEMOSIL LIQUID ANTITHROMBIN XL Instrumentation Laboratory CO JBQ Class II 2004-01-02
K032113 ACIS (AUTOMATED CELLULAR IMAGING SYSTEM) Chroma Vision Medical Systems, Inc. NOT Class II 2003-12-23
K033847 A1CNOW FOR HOME AND PROFESSIONAL USE Metrika, Inc. LCP Class II 2003-12-23
K033612 FACTOR II (PROTHROMBIN) G20210A KIT Roche Diagnostics Corp. NPR Class II 2003-12-18
DEN030005 FACTOR V LEIDEN KIT Roche Diagnostics Corp. NPQ Class II 2003-12-17
K033631 MODIFICATION TO COATEST FACTOR VIII Instrumentation Laboratory CO GGP Class II 2003-12-15
K032952 AIACT KIT Sienco, Inc. JBP Class II 2003-12-12
K033137 POTENS + Wada, Inc. JPA Class II 2003-12-08
K032827 KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501 Tyco Healthcare KSR Class II 2003-12-08
K032874 HBA SPERM-HYALURONAN BINDING ASSAY Biocoat, Inc. POV Class II 2003-11-24
K033548 ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER Roche Diagnostics Corp. KHE Class II 2003-11-24
K030263 IMMUNICON CELLTRACKS ANALYZER Immunicon Corp. GKZ Class II 2003-11-24
K031380 OLYMPUS HBA1C REAGENT, (CATALOG NUMBER OSR6192), OLYMPUS HBA1C CALIBRATOR, (CATOLOG NUMBER ODC3032) Olympus America, Inc. LCP Class II 2003-11-14
K032804 CRYOCHECK WEAK LUPUS POSITIVE CONTROL Precision Biologic GGC Class II 2003-11-03
K031042 ATAC HEMOGLOBIN A1C REAGENT KIT Clinical Data, Inc. LCP Class II 2003-11-03
K032791 GLYCOHEMOSURE HBA1C CONTROL Quantimetrix Corp. GGM Class II 2003-10-30
K032419 QUANTEX D-DIMER Instrumentation Laboratory CO DAP Class II 2003-10-24
K032482 STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM Stanbio Laboratory GKR Class II 2003-10-24
K032342 COULTER LH 750 HEMATOLOGY ANALYZER Beckman Coulter, Inc. GKZ Class II 2003-09-26
K031898 EKF DIAGNOSTIC HEMO CONTROL HEMOGLOBIN MEASUREMENT SYSTEM Ekf Diagnostic GmbH GKR Class II 2003-09-24
K031356 HEMAPROMPT GASTRIC Aerscher Diagnostics KHE Class II 2003-09-24
K031604 GLYCOMARK Tomen America, Inc. NOZ Class II 2003-09-22
K032611 LYPHOCHEK COAGULATION CONTROL, LEVEL 4, MODEL 743 Bio-Rad GGN Class II 2003-09-17
K023582 I-STAT KAOLIN ACT TEST I-Stat Corporation JBP Class II 2003-09-08
K031377 SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560 Dade Behring, Inc. GKP Class II 2003-09-08
K032039 IMMATURE GRANULOCYTE (IG) PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER Sysmex America, Inc. GKZ Class II 2003-09-08
K032524 ADVIA 60 HEMATOLOGY ANALYZER Bayer Healthcare, LLC GKZ Class II 2003-09-08
K030553 ARKIT HBA1C Arkray, Inc. LCP Class II 2003-09-02
K030328 VIDAS D-DIMER NEW (DD2) ASSAY, MODEL 30 442 bioMerieux, Inc. DAP Class II 2003-09-02
K031043 D-10 HEMOGLOBIN A1C Bio-Rad Laboratories, Inc. LCP Class II 2003-08-27
K032203 HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704 Hemocue, Inc. GKR Class II 2003-08-25
K030192 DUET SYSTEM Bioview , Ltd. JOY Class II 2003-08-20
K032000 COULTER LH 500 HEMATOLOGY ANALYZER Beckman Coulter, Inc. GKZ Class II 2003-08-13
K032017 LIQUICHEK D-DIMER CONTROL LEVEL 1, 2 AND 3 Bio-Rad GGN Class II 2003-08-08
K031539 HEMOGLOBIN A1C REAGENT SET Pointe Scientific, Inc., LCP Class II 2003-08-06
K031829 HEMOSIL FACTOR IX DEFICIENT PLASMA Instrumentation Laboratory CO GJT Class II 2003-07-31
K032013 COULTER ACT 5DIFF AL HEMATOLOGY ANALYZER Beckman Coulter, Inc. GKZ Class II 2003-07-24

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