meddevicedb.com FDA Device Reference

Review Panel

Hematology FDA 510(k) Clearances & Devices

Cleared Devices
4,197
Product Codes (page)
41
Latest Decision
2008-01-24

Clearances · page 6 of 42

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K073039 SPERMCHECK VASECTOMY Princeton BioMeditech Corp. POV Class II 2008-01-24
K072869 POINTCARE NOW SYSTEM Pointcare Technologies, Inc. GKZ Class II 2008-01-14
K073431 FORSURE IFOB DUEL SAMPLE FECAL OCCULT BLOOD TEST DEVICE (FOR PROFESSIONAL AND HOME USE); (FOR PROFESSIONAL); (FOR HOME T Tianjin New Bay Bioresearch Co., Ltd. KHE Class II 2008-01-14
K071671 SCANSCOPE XT SYSTEM Aperio Technologies OEO Class II 2007-12-28
K073367 HEMOSIL FIBRINOGEN-C Instrumentation Laboratory CO KQJ Class II 2007-12-27
K073178 HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004 R&D Systems, Inc. JPK Class II 2007-12-27
K071781 PF4 IGG Genetic Testing Institute LCO Class II 2007-12-19
K071562 D3 HEMATOLOGY ANALYZER, MODEL D3 Drew Scientific, Inc. GKZ Class II 2007-12-11
K071265 SMARTCHECK INR SYSTEM Inverness Medical Innovations, Inc. JPA Class II 2007-11-30
K062658 PRIMUS A1CARE ASSAY Primus Corp. LCP Class II 2007-11-26
K072846 CSF AUTOMATED CONTROL, MODELS CSF001, CSF003 R&D Systems, Inc. JPK Class II 2007-11-26
K072268 HC WBC HEMATOLOGY CONTROL, MODEL: WBC00S R&D Systems, Inc. JPK Class II 2007-11-20
K071967 SYSMEX XE-5000 Sysmex America, Inc. GKZ Class II 2007-11-20
K072727 INRATIO 2 PT MONITORING SYSTEM Hemosense, Inc. GJS Class II 2007-10-26
K071737 GENERAL SEMEN ANALYSIS KIT Dyn-Bioshaf (2006) , Ltd. POV Class II 2007-10-25
K071652 HEMOCUE WBC SYSTEM Hemocue AB GKL Class II 2007-10-25
K063295 ACON UTI URINARY TRACT INFECTION TEST STRIPS ACON Laboratories, Inc. LJX Class I 2007-10-12
K071128 SCANSCOPE XT SYSTEM Aperio Technologies NOT Class II 2007-10-10
K071466 DCA VANTAGE, MODEL 5075 Siemens Medical Solutions Diagnostics LCP Class II 2007-10-09
K071681 CYTOMICS FC 500 MPL FLOW CYTOMETER, MODEL # 626554 Beckman Coulter, Inc. GKZ Class II 2007-10-04
K071398 SCANVIEW, MODEL SC-300 Applied Spectral Imaging , Ltd. JOY Class II 2007-10-04
K072304 FIBRINOGEN CALIBRATOR KIT Dade Behring, Inc. GFX Class II 2007-09-19
K070927 HEMOSIL D-DIMER HS Instrumentation Laboratory CO DAP Class II 2007-09-17
K071255 ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A Hyphen Biomed LCO Class II 2007-09-07
K072096 CBC-5D PLUS RETICS HEMATOLOGY CONTROL, MODELS: 5DR03, 5DR04 R&D Systems, Inc. JPK Class II 2007-08-20
K063323 SPECTROLYSE PAI-1, MODEL 101201 American Diagnostica, Inc. GGP Class II 2007-08-15
K070005 HEMOSIL RECOMBIPLASTIN 2G Instrumentation Laboratory CO GJS Class II 2007-08-15
K071319 I-STAT ACTIVATED CLOTTING TIME (ACT) CONTROL SET LEVEL 1 AND LEVEL 2, MODELS 07G82-01, 07G82-02 Bio-Rad, Diagnostics Grp. GGN Class II 2007-06-26
K070819 VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM, AND VARIANT II TURBO LINK HEMOGLOBIN TESTING WITH MODEL, 270-2716, Bio-Rad Laboratories Inc., Clinical Systems Divisi LCP Class II 2007-06-25
K070660 INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TEST Alfa Scientific Designs, Inc. KHE Class II 2007-06-21
K070453 OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROL Olympus Life & Material Science Europa GmbH (Irish GHH Class II 2007-06-11
K063407 BC-3200 AUTO HEMATOLOGY ANALYZER Shenzhen Mindray Bio-Medical Electronics Co., Ltd. GKZ Class II 2007-06-11
K071143 BD TRITEST CD3/CD4/CD45, MODEL 340383 Bd Biosciences GKZ Class II 2007-06-06
K071141 BD TRITEST CD3/CD4/CD45 WITH BD TRUCOUNT ABSOLUTE COUNT TUBES, MODEL 340402 Bd Biosciences GKZ Class II 2007-06-06
K062025 ASPIRINWORKS TEST KIT (11-DEHYDRO THROMBOXANE B2), MODEL 12136 Corgenix, Inc. OBW Class II 2007-05-29
K070910 SYSMEX MODEL UF1000I Sysmex America, Inc. LKM Class II 2007-05-25
K060968 STASIS - I, II AND III; SERATHAN - A, B; INTRIN - EA, SI CALCIUM CHLORIDE 0.02M; FIBRINOGEN CONTROL-NORMAL, LOW Wortham Laboratories, Inc. GIZ Class II 2007-05-15
K071041 COAGUCHEK XS PLUS SYSTEM Roche Diagnostics GJS Class II 2007-05-11
K063693 FORSURE ONE STEP FECAL OCCULT BLOOD (FOB) SCREEN CARD TEST New Bay Bioresearch Co. , Ltd. KHE Class II 2007-05-11
K070452 VARIANT II HEMOGLOBIN A1C PROGRAM WITH MODELS 270-2101NU Bio-Rad Laboratories, Inc. LCP Class II 2007-05-07
K063306 ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CONTROLS, MODEL C2-72 Alfa Wassermann, Inc. LCP Class II 2007-04-17
K070734 MODIFICATION TO: DIRECT ENZYMATIC HBA1C ASSAY KIT, MODEL# DZ168A, DZ168A-CAL, DZ168A-CON Diazyme Laboratories LCP Class II 2007-04-09
K070546 LYPHOCHEK DIABETES CONTROL Bio-Rad Laboratories GGM Class II 2007-04-02
K070635 HEMOSIL PROCLOT Instrumentation Laboratory CO GGP Class II 2007-03-29
K070334 R&D SICKLE QC CONTROL R&D Systems, Inc. GGM Class II 2007-03-29
K063864 QWIKCHECK TEST STRIPS- REAGENT STRIPS FOR SEMEN ANALYSIS Medical Electronic Systems , Ltd. POV Class II 2007-03-26
K063356 STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAK Dade Behring, Inc. DAP Class II 2007-03-23
K063209 HBA1C; CALIBRATOR; CONTROL NORMAL, CONTROL ABNORMAL Thermo Electron OY LCP Class II 2007-03-21
K062306 PLASMACON N, PLASMACON L-1, PLASMACON L-2 R2 Diagnostics, Inc. GGC Class II 2007-03-16
K062203 TINA-QUANT D-DIMER TEST SYSTEM Roche Diagnostics Corp. GHH Class II 2007-03-14
K063673 INNOVACON FLIPCARD FECAL OCCULT BLOOD TEST DEVICE Innovacon, Inc. KHE Class II 2007-03-05
K062840 TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTROLS Biosite Incorporated GGN Class II 2007-03-01
K061991 PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA Helena Laboratories GHR Class II 2007-02-23
K070199 RETIC-CHEX LINEARITY FOR BC Streck JPK Class II 2007-02-23
K070301 HEMOSIL ANTITHROMBIN Instrumentation Laboratory CO JBQ Class II 2007-02-23
K062756 PATHIAM IMAGING SOFTWARE FOR HER2/NEU Bioimagene, Inc. NOT Class II 2007-02-20
K060564 INFINITI SYSTEM AutoGenomics, Inc. NPQ Class II 2007-02-07
K062604 RAPIDTEG TEG-ACT TEST Haemoscope Corp. JBP Class II 2007-01-31
K062925 COAGUCHEK XS SYSTEM Roche Diagnostics Corp. GJS Class II 2007-01-29
K062530 TRIAGE PROTEIN C TEST Biosite Incorporated GGP Class II 2007-01-29
K063823 COAGUCHEK XS PT CONTROLS Roche Diagnostics Corp. GGN Class II 2007-01-29
K062615 VISION BIOSYSTEMS PROGESTERONE RECEPTOR PGR CLONE 16 Vision Biosystems, Inc. MXZ Class II 2007-01-29
K061602 DUET SYSTEM Bioview , Ltd. JOY Class II 2007-01-23
K063679 ACL TOP Instrumentation Laboratory CO GKP Class II 2007-01-12
K061613 VENTANA IMAGE ANALYSIS SYSTEM - PATHWAY HER2 (4B5) Tripath Imaging NQN Class II 2007-01-10
K062755 IKONISCOPE ONCOFISH BLADDER TEST SYSTEM Ikonisys, Inc. JOY Class II 2007-01-04
K063643 MODIFICATION TO VARIANT II: HEMOGLOBIN A1C PROGRAM, BETA-THALASSEMIA SHORT PROGRAM AND TOTAL GHB PROGRAM Bio-Rad Laboratories Inc., Clinical Systems Divisi LCP Class II 2006-12-27
K063218 E-CHECK (XE) Streck JPK Class II 2006-12-14
K061805 STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRM Diagnostica Stago, Inc. GIR Class I 2006-12-06
K063400 VARIANT II TURBO HEMOGLOBIN A1C PROGRAM, HEMOGLOBIN TESTING SYSTEM WITH CDM 4.0 Bio-Rad Laboratories, Inc. LCP Class II 2006-12-01
K062774 BELMONT BUDDY PLUS FLUID WARMER Belmont Instrument Corp. BSB Class II 2006-10-19
K052223 ACCESS EPO ASSAY Beckman Coulter, Inc. GGT Class II 2006-10-06
K061616 COULTER LH 780 HEMATOLOGY ANALYZER Beckman Coulter, Inc. GKZ Class II 2006-10-04
K062428 VENTANA IMAGE ANALYSIS SYSTEM, MODEL VIAS Tripath Imaging, Inc. NQN Class II 2006-09-29
K060953 OCCULTECH FECAL OCCULT BLOOD RAPID TEST Yd Diagnostics Corp. KHE Class II 2006-09-18
K062087 BD FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 339473; (4-2-2), MODEL 338962 Bd Biosciences GKZ Class II 2006-09-14
K062430 HEMOSIL PROTEIN C Instrumentation Laboratory CO GGP Class II 2006-09-01
K062431 HEMOSIL LIQUID ANTITHROMBIN Instrumentation Laboratory CO JBQ Class II 2006-09-01
K060423 CYAN DXD, MULTITEST CD8/CD4/CD3, CD3-FITC, CD3-RPE, CD3-APC AND FLUOROSPHERES Dakocytomation California, Inc. GKZ Class II 2006-08-15
K060978 COAGUCHEK XS SYSTEM Roche Diagnostics GJS Class II 2006-08-11
K061392 IKONISCOPE FASTFISH AUTO/AMNIOCYTE TEST SYSTEM Ikonisys, Inc. JOY Class II 2006-08-01
K061803 STA - CONTROL LA 1+2 Diagnostica Stago, Inc. GGC Class II 2006-07-28
K061574 COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632 Beckman Coulter, Inc. GKZ Class II 2006-07-21
K060489 DADE PFA-100 PLATELET FUNCTION ANALYZER AND REAGENTS Dade Behring, Inc. JOZ Class II 2006-07-21
K061065 FECAL OCCULT BLOOD CARD TEST, MODEL F735-A, FECAL OCCULT BLOOD CARD KIT, MODEL F735-25 Teco Diagnostics KHE Class II 2006-07-14
K061667 CELL-DYN RUBY SYSTEM Abbott Laboratories GKZ Class II 2006-07-10
K061511 R&D CBC-3D + CRP HEMATOLOGY CONTROL R&D Systems, Inc. JPK Class II 2006-07-10
K061150 SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XT-SERIES Sysmex America, Inc. GKZ Class II 2006-07-06
K053571 MICROGEL ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM, MICROGEL ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM Interlab S.R.L. JBD Class II 2006-06-30
K052291 CAPILLARY'S HEMOGLOBIN(E) (PN 2007) Sebia GKA Class II 2006-06-27
K061360 NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN ESTROGEN RECE[PTOR ANTIBODY (CLONE SP1) Lab Vision Corp. MYA Class II 2006-06-27
K061047 HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 111801 Hemocue AB GKR Class II 2006-06-08
K060375 BD MULTITEST 6-COLOR TBNK REAGENT WITH BD TRUCOUNT TUBES WITH MODELS 337 AND 166 Bd Biosciences GKZ Class II 2006-06-06
K060463 HEMA SCREEN SPECIFIC IFOBT Immunostics Inc., KHE Class II 2006-06-06
K061320 R&D LH-NRBC HEMATOLOGY CONTROL R&D Systems, Inc. JPK Class II 2006-06-02
K060227 VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11) Vision Biosystems, Inc. MYA Class II 2006-05-25
K050367 BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6 Hyphen Biomed KFF Class II 2006-05-24
K061064 COULTER LIN-C LINEARITY CONTROL, MODELS 7547065, 723503 Beckman Coulter, Inc. JPK Class II 2006-05-17
K061014 ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP Helena Laboratories JPA Class II 2006-05-10
K060284 CRYOCHECK CLOT APCR Precision Biologic, Inc. GGW Class II 2006-05-10

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