meddevicedb.com FDA Device Reference

Review Panel

Hematology FDA 510(k) Clearances & Devices

Cleared Devices
4,197
Product Codes (page)
33
Latest Decision
2017-03-16

Clearances · page 3 of 42

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K163498 VALIDATE Heparin Calibration Verification/Linearity Test Kit Maine Standards Company, LLC GGN Class II 2017-03-16
K170314 ACL AcuStar Instrumentation Laboratory CO JPA Class II 2017-03-03
K153538 Dextramer CMV Kit Immudex Aps GKZ Class II 2017-03-02
K161316 George King Coumadin Plasma George King Bio-Medical, Inc. GGN Class II 2017-02-23
K162281 CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2) Sebia LCP Class II 2017-02-17
K163554 hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test Immunostics Inc., KHE Class II 2017-01-17
K162705 VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit Maine Standards Company, LLC GGN Class II 2017-01-05
K162688 Sysmex CS-2100i Siemens Healthcare Diagnostics Products GmbH JPA Class II 2016-12-26
K160538 Sysmex XN-L Automated Hematology Analyzer Sysmex America, Inc. GKZ Class II 2016-12-22
K160590 XN CHECK Streck JPK Class II 2016-12-22
K160585 XN CAL Streck KRX Class II 2016-12-22
K160588 XN CHECK BF Streck JPK Class II 2016-12-22
K160586 XN-L CHECK Streck JPK Class II 2016-12-22
K160415 GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation) Instrumentation Laboratory CO GKF Class II 2016-12-14
K162420 Sysmex Automated Blood Coagulation Analyzer CS-5100 Siemens Healthcare Diagnostics Products GmbH JPA Class II 2016-12-12
K162227 STA® - Liatest® D-Di Diagnostica Stago DAP Class II 2016-12-10
K161329 Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channel Chrono-Log Corp. JOZ Class II 2016-12-02
K162414 UniCel DxH SlideMaker Stainer Coulter Cellular Analysis System Beckman Coulter, Inc. GKZ Class II 2016-11-29
K162462 AMICUS Separator System, AMICUS Separator System; Refurbished Fresenius Kabi USA,Llc GKT Class II 2016-11-23
K160762 Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set Diazyme Laboratories LCP Class II 2016-11-21
K161493 YO Home Sperm Test Medical Electronic Systems , Ltd. POV Class II 2016-11-08
K160885 HemosIL D-Dimer HS Instrumentation Laboratory CO DAP Class II 2016-10-27
K151964 Xprecia Stride Coagulation System, Xprecia System PT Controls Siemens Healthcare Diagnostics GJS Class II 2016-09-30
K161317 Sysmex Automated Blood Coagulation Analyzer CS-5100 Siemens Healthcare Diagnostics Products GmbH JPA Class II 2016-09-02
K160606 BC-5D Hematology Control R&D Systems, Inc. JPK Class II 2016-09-01
K160429 BC-5390 Auto Hematology Analyzer Mindray Bio-Medical Electronics Co., Ltd. GKZ Class II 2016-09-01
K161312 Sysmex Automated Blood Coagulation Analyzer CS-2100i Siemens Healthcare Diagnostics Products GmbH JPA Class II 2016-09-01
K153137 HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls Instrumentation Laboratory CO LCO Class II 2016-07-08
K161364 BinaxNOW G6PD Test Alere Scarborough, Inc. JBF Class II 2016-06-17
K152961 VALIDATE D-Dimer Calibration Verification/Linearity Test Kit Maine Standards Company, LLC GGN Class II 2016-06-03
K152776 Glocyte Automated Cell Counter System Advanced Instruments, Inc. GKL Class II 2016-05-27
K153683 Trak Male Fertility Testing System Sandstone Diagnostics, Inc. POV Class II 2016-05-16
K160922 FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Link); FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use (Link) Dako North America, Inc. MXZ Class II 2016-05-03
K160445 HemosIL Silica Clotting Time Instrumentation Laboratory CO GFO Class II 2016-03-16
K150144 VisuCon-F Low Fibrinogen Control Plasma Affinity Biologicals, Inc. GGN Class II 2016-03-06
K160276 ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS) Instrumentation Laboratory CO GKP Class II 2016-03-03
K143470 Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set Diazyme Laboratories GIS Class II 2016-01-31
K142664 URight Hemoglobin A1c system, FORA A1c System Taidoc Technology Corporation LCP Class II 2016-01-29
K151259 Sysmex Automated Blood Coagulation Analyzer CS-2100i Siemens Healthcare Diagnostics Products GmbH JPA Class II 2016-01-26
K150678 Sysmex Automated Blood Coagulation Analyzer CS-5100 Siemens Healthcare Diagnostic Products GmbH JPA Class II 2016-01-11
K150815 BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto CD4/Hb Cartridge Kit Becton, Dickinson and Company PMG Class II 2015-12-17
K150877 ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS Instrumentation Laboratory CO GKP Class II 2015-12-13
K151133 PENTRA XLR HORIBA ABX SAS GKZ Class II 2015-12-09
K143577 XW-100 Automated Hematology Analyzer, XW QC CHECK Sysmex America, Inc. GKZ Class II 2015-10-12
K140827 SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control Set Sd Biosensor, Inc. LCP Class II 2015-09-30
K151809 Alere Afinion HbA1c, Alere Afinion AS100 Analyzer Alere Technologies AS LCP Class II 2015-09-25
K143348 BC-3600 Auto Hematology Analyzer Mindray Bio-Medical Electronics Co., Ltd. GKZ Class II 2015-08-21
K143325 OC-Light S FIT Eiken Chemical Co., Ltd. KHE Class II 2015-08-20
K151867 STA R MAX Diagnostica Stago S.A.S JPA Class II 2015-08-07
K141427 ACCUMETRICS,INC. VERIFYNOW PRUTEST, ACCUMETRICS, INC. VERIFYNOW PRUTEST Accumetrics, Inc. JOZ Class II 2015-07-24
K142965 Virtuoso System for IHC PR (1E2) using iScan HT Ventana Medical Systems, Inc. OEO Class II 2015-07-16
K151534 HemosIL D-Dimer HS Instrumentation Laboratory CO DAP Class II 2015-07-06
K150041 CORA (Coagulation Resonance Analysis) System Coramed Technologies, LLC JPA Class II 2015-06-26
K141932 AQUIOS CL FLOW CYTOMETER, AQUIOS TETRA-1 PANEL,AQUIOS TETRA-2+PANEL, AQUIOS IMMUNO-TROL, AQUIOS IMMUNO-TROL LOW, AQUIOS Beckman Coulter, Inc. OYE Class II 2015-04-10
K141944 HOME ACCESS AIC TEST Home Access Health Corp. LCP Class II 2015-03-13
K141468 BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow cytometer (4-3-3 configuration) Bd Biosciences OYE Class II 2015-02-27
K140957 GENASIS HIPATH IHC FAMILY Applied Spectral Imaging , Ltd. NQN Class II 2015-01-15
K140893 CORA (COAGULATION RESONANCE ANALYSIS) SYSTEM WITH PLATELET MAPPING ASSAY Coramed Technologies, LLC JOZ Class II 2015-01-03
K141161 ABX MICROS ES 60 CT; (OPEN TUBE MODEL), (CLOSE TUBE MODEL) HORIBA ABX SAS GKZ Class II 2014-12-20
K142789 A1c iGear System Sakae Corporation LCP Class II 2014-12-16
K142132 POOL NORM Diagnostics Stago S.A.S. GGN Class II 2014-12-12
K141962 XN CAL Streck KRX Class II 2014-12-05
K141964 XN CHECK Streck JPK Class II 2014-12-05
K141957 XN CHECK BF Streck JPK Class II 2014-12-05
K141681 SYSMEX XN SERIES Sysmex America, Inc. GKZ Class II 2014-12-05
K141955 XN CAL PF Streck KRX Class II 2014-12-05
K140911 UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM/ UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEM Beckman Coulter, Inc. GKZ Class II 2014-09-05
K141144 STA LIATEST D-DI Diagnostica Stago DAP Class II 2014-09-03
K133582 HEMOSIL D-DIMER HS 500 CONTROL Instrumentation Laboratory GGN Class II 2014-08-15
K133803 DIAZYME GLYCATED SERUM PROTEIN POC TEST KIT Diazyme Laboratories LCP Class II 2014-08-06
K141109 APERIO EPATHOLOGY EIHC IVD SYSTEM Leica Biosystems Imaging, Inc. NOT Class II 2014-07-29
K141750 HEMOCUE HBA1C 501 GLYCOSYLATED HEMOGLOBIN MONITORING SYSTEM Infopia Co, Ltd. LCP Class II 2014-07-24
K140829 UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN A1C3 (HBA1C3) REAGENT Beckman Coulter, Inc. LCP Class II 2014-07-14
K140801 VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEM Bio-Rad Laboratories, Inc. LCP Class II 2014-06-25
K132978 IMPACT DX FACTOR V LEIDEN AND FACTOR II GENOTYPING TEST Sequenom, Inc. PHJ Class II 2014-06-13
K122556 VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11) Leica Biosystems Newcastle, Ltd. MYA Class II 2014-05-19
K132167 I-CHROMA IFOB WITH I-CHROMA READER Boditech Med, Inc. OOX Class II 2014-05-02
K130014 A1C GEAR SYSTEM Sakae Corporation LCP Class II 2014-04-04
K131140 OMNYX IDP FOR HER2 MANUAL APPLICATION Omnyx, LLC OEO Class II 2014-04-01
K133344 MINICAP HB A1C, MINICAP FLEX-PIERCING, HB A1C CAPILLARYS CONTROLS, HBA1C CAPILLARYS CALIBRATORS Sebia LCP Class II 2014-03-28
K140465 VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER Ventana Medical Systems, Inc. NQN Class II 2014-03-20
K133005 HEMOSIL VON WILLEBRAND ACTIVITY ASSAY Instrumentation Laboratory CO GGP Class II 2014-03-13
K131307 ADVIA CHEMISTRY FRUCTOSAMINE ASSAY, ADVIA CHEMISTRY FRUCTOSAMINE CALIBRATOR Siemens Healthcare Diagnostics, Inc. LCP Class II 2014-01-24
K132722 HEMOSIL RECOMBIPLASTIN 2G (8 ML VIAL) Instrumentation Laboratory CO GJS Class II 2014-01-22
K132076 REAGENT, RUSSEL VIPER VENOM - LA CONFIRM Dsrv, Inc. GIR Class I 2014-01-10
K132130 REAGENT, RUSSEL VIPER VENOM - LA SCREEN Dsrv, Inc. GIR Class I 2014-01-10
K122162 AGGREGUIDE Aggredyne, Inc. JOZ Class II 2013-12-20
K130861 MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, READY-TO-USE (LINK) Dako North America, Inc. MXZ Class II 2013-12-09
K130515 VIRTUOSO SYSTEM FOR IHC ER (SPI) Ventana Medical Systems, Inc. NQN Class II 2013-11-22
K121516 VIRTUOSO SYSTEM FOR IHC HER2 (4B5) Ventana Medical Systems, Inc. NQN Class II 2013-09-26
K130021 PHILIPS HERCEPTEST DIGITAL SCORE Philips Medical Systems Nederland B.V. OEO Class II 2013-09-19
K122143 VIRTUOSO SYSTEM FOR IHC PR (1E2) BENCHMARK ULTRA STAINER Ventana Medical Systems, Inc. NQN Class II 2013-09-19
K130373 NAVIOS FLOW CYTOMETER SYSTEM Beckman Coulter, Inc. OYE Class II 2013-09-18
K131508 VYSIS D7S486/CEP 7 FISH PROBE KIT Abbott Molecular, Inc. PFG Class II 2013-09-13
K121033 VIRTUOSO SYSTEM FOR IHC KI-67 (30-9) Ventana Medical Systems, Inc. NOT Class II 2013-09-06
K122553 MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM ACON Laboratories, Inc. GKR Class II 2013-08-05
DEN130010 VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION) Abbott Molecular, Inc. PDO Class II 2013-07-29
K121445 TETRACHROME REAGENTS AND TETRACXP SYSTEM Beckman Coulter, Inc. OYE Class II 2013-07-26
K130962 R&D 5D RETIC HEMATOLOGY CONTROL R&D Systems, Inc. JPK Class II 2013-07-24
K120977 DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DIRECTCHECK CONTROLS FOR HEMOCHRON JR. MIC International Technidyne Corp. GGN Class II 2013-07-03

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