Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Biological StainsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cell And Tissue Culture ProductsCFR Sub-Part
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart E—Specimen Preparation ReagentsCFR Sub-Part
- Subpart F—Automated and Semi-Automated Hematology DevicesCFR Sub-Part
- GKFInstrument, Hematocrit, Automated2Product Code
- GKHApparatus, Automated Blood Cell Diluting1Product Code
- GKJSpinner, Slide, Automated1Product Code
- GKLCounter, Cell, Automated (Particle Counter)2Product Code
- GKNTimer, Clot, Automated2Product Code
- GIZPlasma, Control, Normal2Product Code
- GKBDevice, Automated Sedimentation Rate1Product Code
- GGCControl, Plasma, Abnormal2Product Code
- GGNPlasma, Coagulation Control2Product Code
- GHKCentrifuge, Microsedimentation1Product Code
- GHRReagent, Platelet Aggregation2Product Code
- GIEFibrometer2Product Code
- GKPInstrument, Coagulation, Automated2Product Code
- GKRSystem, Hemoglobin, Automated2Product Code
- GKXInstrument, Automated Platelet Counting2Product Code
- GKZCounter, Differential Cell2Product Code
- JBTTimer, Coagulation2Product Code
- JBWRed-Cell Indices, Measured2Product Code
- JOXAnalyzer, Heparin, Automated2Product Code
- JOYDevice, Automated Cell-Locating2Product Code
- JOZSystem, Automated Platelet Aggregation2Product Code
- K191364T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS 01, PL Chip Reservoir Set for T-TAS 01, BAPA tube for T-TAS 012Cleared 510(K)
- K181777AggreGuide A-100 ADP2Cleared 510(K)
- K163274AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument2Cleared 510(K)
- K161329Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channel2Cleared 510(K)
- K141427ACCUMETRICS,INC. VERIFYNOW PRUTEST, ACCUMETRICS, INC. VERIFYNOW PRUTEST2Cleared 510(K)
- K140893CORA (COAGULATION RESONANCE ANALYSIS) SYSTEM WITH PLATELET MAPPING ASSAY2Cleared 510(K)
- K122162AGGREGUIDE2Cleared 510(K)
- K103555MULTIPLATE 5.0 AGGREGOMETER2Cleared 510(K)
- K060489DADE PFA-100 PLATELET FUNCTION ANALYZER AND REAGENTS2Cleared 510(K)
- K050265CHRONO-LOG WHOLE BLOOD LUMI-AGGREGOMETER, MODEL 7002Cleared 510(K)
- K051231VERIFYNOW-P2Y12 ASSAY2Cleared 510(K)
- K042423VERIFYNOW-ASPIRIN ASSAY2Cleared 510(K)
- K041502THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY2Cleared 510(K)
- K032951CHRONO-LOG WHOLE BLOOD AGGREGOMETER, MODELS 591A AND 592A2Cleared 510(K)
- K023761PLATELETWORKS, MODELS PW-A, PW-C2Cleared 510(K)
- K012701ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - ASA (RPFA-ASA)2Cleared 510(K)
- K013596MODIFICATION TO ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - TRAP (RPFA-TRAP)2Cleared 510(K)
- K011337ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA)2Cleared 510(K)
- K012723PLATELETWORKS2Cleared 510(K)
- K002885DADE PFA-100 PLATELET FUNCTION ANALYZER MODEL-100, DADE PFA COLLEGEN/EPINEPHRINE TEST CARTRIDE, DADE PFA COLLEAGEN /ADP2Cleared 510(K)
- K992531ULTEGRA SYSTEM ANALYZER, ULTEGRA SYSTEM RPFA-TRAP TEST CARTIDGES, ULTEGRA SYSTEM RPFA-TRAP LEVEL ONE QC, ULTEGRA SYSTEM2Cleared 510(K)
- K990398PLATELETWORKS2Cleared 510(K)
- K970505DADE PFA-100 PLATELET FUNCTION ANALYZER/PFA COLLAGEN/EPINEPHRINE TEST CARTRIDGE/PFA COLLAGEN/ADP TEST CARTRIDGE/2Cleared 510(K)
- K962426CHRONO-LOG WHOLE BLOOD AGGREGOMETER (WBA) 591/5922Cleared 510(K)
- K954997CENTOCOR AGGRESTAT, COLLAGEN REAGENT, CONTROL REAGENT2Cleared 510(K)
- K940792AGGRO/LINK VW COFACTOR SOFTWARE2Cleared 510(K)
- K862302BLOOD PLATELET ASSAY METHOD & APPARATUS2Cleared 510(K)
- K851669MONITOR IV PLUS2Cleared 510(K)
- K800432HELENA RISTOCETIN2Cleared 510(K)
- K800146PLATELET AGGREGATION REAGENTS2Cleared 510(K)
- K791577ELVI 840 AGGREGOMETER2Cleared 510(K)
- K790769BETA/PAK2Cleared 510(K)
- K781693COLLAGENREAGENT HORM2Cleared 510(K)
- K781807REAGENT, FIREFLY #3952Cleared 510(K)
- K780285SOLUBLE COLLAGEN2Cleared 510(K)
- K780047PLATELET AGGREGATING REAGENTS2Cleared 510(K)
- K770395THROMBO-CETIN (RISTOCETIN)2Cleared 510(K)
- K760893AGGRECETIN2Cleared 510(K)
- JPASystem, Multipurpose For In Vitro Coagulation Studies2Product Code
- JPJRed-Cell Indices, Calculated2Product Code
- JWODevice, Blood Volume Measuring2Product Code
- KQGInstrument, Coagulation2Product Code
- KQHRed-Cell Indices2Product Code
- LGPAssay, Alpha-2-Antiplasmin2Product Code
- LKMCounter, Urine Particle2Product Code
- LLGKit, Igg, Platelet Associated2Product Code
- MAMDna-Probe, B And T Lymphocyte2Product Code
- OBW11-Dehydro Thromboxane B2 Kit, Urinary2Product Code
- OYEFlow Cytometric Reagents And Accessories.2Product Code
- PMGAutomated Multicolor Fluorescent Imaging Cytometric Analysis System2Product Code
- POVSemen Analysis Device2Product Code
- QFRCoagulation System For The Measurement Of Whole Blood Viscoelastic Properties2Product Code
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
- Subpart G—Manual Hematology DevicesCFR Sub-Part
- Subpart G—Tumor Associated Antigen immunological Test SystemsCFR Sub-Part
- Subpart H—Hematology Kits and PackagesCFR Sub-Part
- Subpart I—Hematology ReagentsCFR Sub-Part
- Subpart J—Products Used In Establishments That Manufacture Blood and Blood ProductsCFR Sub-Part
- Subpart K—Products Used In Establishments That Manufacture Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)CFR Sub-Part
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - ASA (RPFA-ASA)
- Page Type
- Cleared 510(K)
- 510(k) Number
- K012701
- 510(k) Type
- Traditional
- Applicant
- ACCUMETRICS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/12/2002
- Days to Decision
- 302 days
- Submission Type
- Summary