meddevicedb.com FDA Device Reference

Review Panel

Hematology FDA 510(k) Clearances & Devices

Cleared Devices
4,197
Product Codes (page)
37
Latest Decision
2013-05-31

Clearances · page 4 of 42

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K120900 I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2 Cliniqa Corporation GGN Class II 2013-05-31
K121467 EUROTROL HEMATOCRIT CONTROL Eurotrol B.V. GLK Class II 2013-05-10
K130990 VARIANT(TM) II TURBO HBA1C KIT - 2.0 Bio-Rad Laboratories, Inc., Clinical Systems Divis LCP Class II 2013-05-09
K130860 VARIANT II HEMOGLOBIN A1C PROGRAM (NEW), VARIANT II HEMOGLOBIN TESTING SYSTEM WITH CDM SOFTWARE, CDM SOFTWARE Bio-Rad Laboratories, Inc., Clinical Systems Divis LCP Class II 2013-04-25
K122584 HEMOSIL READIPLAS TIN Instrumentation Laboratory CO GJS Class II 2013-03-24
K120771 UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM Beckman Coulter, Inc. GKZ Class II 2013-03-22
K120014 STA- COAG CONTROL (N+ABN) PLUS Diagnostica Stago, Inc. GGN Class II 2013-03-14
K120663 MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPI Dako North America, Inc. MYA Class II 2013-02-12
K130090 STA COMPACT MAX Diagnostica Stago, Incorporated JPA Class II 2013-02-12
K112120 DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET Diazyme Laboratories GHH Class II 2013-01-24
K121752 AVIE TOTAL HB TEST SYSTEM Mec Dynamics Corp GKR Class II 2013-01-07
K121397 OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 TEST KIT SEKISUI Diagnostics, LLC KHE Class II 2012-12-28
K113506 IND ONE STEP OCCULT BLOOD (FOB) TEST Ind Diagnostics, Inc. KHE Class II 2012-12-19
K110215 CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY Ventana Medical Systems, Inc. MYA Class II 2012-12-17
K121842 ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C Axis-Shield Diagnostics, Ltd. LCP Class II 2012-12-12
K122101 CAPILLARYS HEMOGLOBIN HBA1C CAPILLARYS 2 FLEX PIERCING CAPILLARYS HBA1C CONTROLS CAPILLARYS HBA1C C Sebia LCP Class II 2012-12-06
K122472 VARIANT II TURBO HBA1C KIT-2.0 VARIANT II TURBO HEMOGLOBIN TESTING SYSTEM Bio-Rad Laboratories, Inc., Clinical Systems Divis LCP Class II 2012-10-26
K120747 XN CAL PF Streck KRX Class II 2012-10-22
K120742 XN CHECK Streck JPK Class II 2012-10-19
K120745 XN CAL Streck KRX Class II 2012-10-19
K120744 XN CHECK BF Streck JPK Class II 2012-10-19
K112605 SYSMEX XN-SERIES Sysmex America, Inc. GKZ Class II 2012-10-19
K120199 GLYCOSYLATED HEMOGLOBIN ASSAY; CLINICAL CHEMISTRY Beckman Coulter, Inc. LCP Class II 2012-10-12
K111128 LABONACHECK A1C Ceragem International, Inc. LCP Class II 2012-09-13
K121492 UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN ALC-(HBA1C-) REAGENT Beckman Coulter, Inc. LCP Class II 2012-09-11
K121366 HEMOCUE HBA1C 501 Infopia Co, Ltd. LCP Class II 2012-09-07
K111914 VIRTUAL SLIDE SYSTEM, OLYMPUS VS800 SYSTEM Olympus America Inc. / Scientific Equipment Group OEO Class II 2012-08-21
K113437 ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGENT, ACE T4 REAGENT, ACE FERRITIN REAGENT Alfa Wassermann Diagnostic Technologies, Inc. LCP Class II 2012-08-06
K111534 ABACUS 3CP Diatron U.S., Inc. GKZ Class II 2012-08-02
K112818 VIDAS D-DIMER EXCLUSION II (DEX2) bioMerieux, Inc. DAP Class II 2012-07-31
K103555 MULTIPLATE 5.0 AGGREGOMETER Verum Diagnostica GmbH JOZ Class II 2012-07-27
K121350 VIRTUSO SYSTEM FOR IHC (DO-7) Ventana Medical Systems, Inc. NOT Class II 2012-06-01
K112550 CAPILLARYS HEMOGLOBIN, CAPILLARYS FLEX PIERCING SYSTEM Sebia GKA Class II 2012-05-25
K112491 SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 2 Sebia GKA Class II 2012-05-24
K120497 EASYRA HBALC REGENT EASYCAL HBLC CALIBRATOR EASYQC HBALC MATERIAL Medica Corp. LCP Class II 2012-05-14
K110212 INRATIO2 PI/NR MONITORING SYSTEM; INRATIO PT/INR TEST STRIP Alere San Diego, Inc (Formally Biosite Incorporate GJS Class II 2012-05-01
K111872 VIRTUOSO SYSTEM FOR IHC P53 (DO-7) Ventana Medical Systems, Inc. NQN Class II 2012-04-19
K111999 HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINAL Healgen Scientific,, LLC JIO Class II 2012-04-17
K112755 ABACUS 5 Diatron U.S., Inc. GKZ Class II 2012-03-27
K111869 VIRTUOSO SYSTEM FOR IHC PR (IE2) Ventana Medical Systems, Inc. NQN Class II 2012-03-05
K111755 VIRTUOSO SYSTEM FOR IHC KI-67 (30-9) Ventana Medical Systems, Inc. NOT Class II 2012-02-22
K111221 MISSION U500 URINE ANALYZER ACON Laboratories, Inc. JIO Class II 2012-01-18
K113211 HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL Instrumentation Laboratory CO GGN Class II 2012-01-04
K110313 TINA-QUANT HBA1C GEN.2 Roche Diagnostics LCP Class II 2011-12-23
K111204 CELL-DYN 22 PLUS CALIBRATOR Streck KRX Class II 2011-12-22
K111211 CELL-DYN 22 PLUS CONTROL Streck GLQ Class II 2011-12-22
K110381 CELL-DYN EMERALD 22 SYSTEM Abbott Laboratories GKZ Class II 2011-12-22
K102908 NOFACT IX R2 Diagnostics, Inc. GJT Class II 2011-12-19
K102851 NOFACT VIII R2 Diagnostics, Inc. GJT Class II 2011-12-19
K102644 ADVIA 2120 WITH AUTOSLIDE SYSTEM, AND ADVIA 2120I Siemens Healthcare Diagnostics GKZ Class II 2011-11-23
K112015 PREMIER HB9210 HBA1C ANALYZER Primus Corporation Dba Trinity Biotech LCP Class II 2011-11-22
K112639 THE BELMONT BUDDY LITE FLUID WARMER Belmont Instrument Corp. BSB Class II 2011-11-16
K103818 CONFIRM ANTI-PROGESTORONE RECEPTOR (1E2) RABBIT MONOCLONAL PRIMARY ANTIBODY Ventana Medical Sytems, Inc. MXZ Class II 2011-11-16
K111822 STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH Diagnostica Stago, Inc. KFF Class II 2011-10-26
K110432 VISUCON-F FROZEN COAG SCREEN N, VISUCON-F FROZEN COAG SCREEN ABN Affinity Biologicals, Inc. GGN Class II 2011-10-20
K111543 VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5) Ventana Medical Systems, Inc. NOT Class II 2011-10-12
K102778 CELLAVISION DM1200 WITH THE BODY FLUID APPLICTION CellaVision AB JOY Class II 2011-09-16
K110309 FOB ONE STEP RAPID TEST Orient Gene Biotech KHE Class II 2011-09-14
K110934 ADVIA CHEMISTRY HEMOGLOBIN A1C_3 (A1C_3) AUTOMATED PRETREATMENT ASSAY Siemens Healthcare Diagnostics LCP Class II 2011-08-25
K110031 HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM Instrumentation Laboratory CO GIR Class I 2011-08-24
K101533 EX-TEM. FIB-TEM, AND AP-TEM FOR ROTEM DELTA THROMBOELASTOMETRY SYSTEM Tem Innovations GmbH JPA Class II 2011-08-10
K093548 AVIE A1C TEST SYSTEM Mec Dynamics Corp LCP Class II 2011-07-20
K110237 HEMOSIL FACTOR VIII DEFICIENT PLASMA Instrumentation Laboratory CO GJT Class II 2011-07-08
K100716 AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5 Aalto Scientific, Ltd. GGN Class II 2011-06-23
K111339 HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS) Medtronic, Inc. JOX Class II 2011-06-08
K100943 INVADER FACTOR II Hologic, Inc. NPR Class II 2011-06-02
K100980 INVADER FACTOR V Hologic, Inc. NPQ Class II 2011-06-01
K110718 CELL-CHEX WITH CPPD CRYSTALS Streck GLQ Class II 2011-05-26
K100547 ELITECH CLINICAL SYSTEMS HBA1C REAGENT, ELITECH CLINCAL SYSTEM HBA1C CALIBRATOR SET, ELITECH CLINICAL Seppim S.A.S. LCP Class II 2011-05-19
K110188 DIAZYME GLYCATED SERUM PROTEIN ASSAY / CALIBRATOR KIT / CONTROL KIT Diazyme Laboratories LCP Class II 2011-05-17
K110303 STRATUS CS ACUTE CARE D-DIMER Siemens Healthcare Diagnostics DAP Class II 2011-05-16
K100987 INVADER MTHFR 677 Hologic, Inc. OMM Class II 2011-05-13
K102510 DIMENSIONS HB1C KIT, MODEL DF105A Siemens Healthcare Diagnostics LCP Class II 2011-05-13
K101578 R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL R&D Systems, Inc. JPK Class II 2011-04-28
K100496 INVADER MTHFR 1298 Hologic, Inc. OMM Class II 2011-04-25
K102552 HEMOSIL LA POSITIVE CONTROL Instrumentation Laboratory CO GGC Class II 2011-04-05
K102164 HEMOSIL PROTEIN S ACTIVITY ASSAY Instrumentation Laboratory CO GGP Class II 2011-03-17
K102064 BD FACS SAMPLE PREP ASSISTANT III (SPA III) Becton, Dickinson & CO GKZ Class II 2011-03-07
K110393 EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM; EKF-DIAGNOSTIC HEMOGLOBIN MICROCUVETTES (MODIFIED CURVETTE W Ekf-Diagnostic GmbH GKR Class II 2011-03-04
K110056 AFINION ANALYZER Axis-Shield Poc AS LCP Class II 2011-02-15
K102045 DIMENSION VISA HBA1C, MODEL K3105A Siemens Heatlhcare Diagnostics, Inc. LCP Class II 2011-02-14
K102664 HEMA SCREEN ER Immunostics Inc., KHE Class II 2011-01-28
K102914 TQ HBA1C GEN3 Roche LCP Class II 2011-01-20
K090105 LUPOTEK KCT R2 Diagnostics, Inc. GGW Class II 2010-12-30
K100790 COULTER LIN-X LINEARITY CONTROL, MODEL A81196 Beckman Coulter, Inc. JPK Class II 2010-12-21
K093848 PT-MULTI-CALIBRATOR, MODEL OPAT07 Dade Behring, Inc. GGN Class II 2010-12-20
K100103 SPECIALTY ASSAYED CONTROL-2 Helena Laboratories GGC Class II 2010-12-15
K103314 CLOTRAC HEPARINASE TEST CARTIDGE (HTC) COAGULATION CONTROL Medtronic, Inc. GGN Class II 2010-12-03
K103313 HEPARIN ASSAY CONTROLS Medtronic, Inc. GGN Class II 2010-12-01
K093626 INNOVANCE D-DIMER, MODEL OPBP09 Siemens Healthcare Diagnostics DAP Class II 2010-11-29
K100607 COULTER 4C-EX 300 CELL CONTROL Beckman Coulter, Inc. JPK Class II 2010-11-18
K102953 HEPARIN DOSE RESPONSE CARTRIDGE Medtronic, Inc. JOX Class II 2010-11-04
K092333 PATHIAM SYSTEM WITH ISCAN FOR P53 AND KI-67 Bioimagene, Inc. NQN Class II 2010-10-27
K100489 DXH 300 COULTER CELLULAR ANALYSIS SYSTEM, DXH 300C COULTER CELLULAR ANALYSSI SYSTEM MODEL: 71772, 71771 Beckman Coulter Cellular GKZ Class II 2010-10-26
K101911 IMMUKNOW-THE CYLEX IMMUNE CELLFUNCTION ASSAY Cylex, Inc. NID Class II 2010-10-18
K101271 HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XX Medtronic, Inc. JOX Class II 2010-10-13
K101831 ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800 Bionostics, Inc. OSL Class II 2010-10-01
K091539 IQ 200 URINE ANALIZER BODY FLUIDS MODULE Iris Diagnostics GKL Class II 2010-08-31
K100304 ST AIA PACK HBA1C Tosoh Bioscience, Inc. LCP Class II 2010-08-27
K100684 CELLTRACKS AUTOPREP SYSTEM MODEL:9541 Veridex, LLC GKH Class I 2010-08-26

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