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510(k) K141427

ACCUMETRICS,INC. VERIFYNOW PRUTEST, ACCUMETRICS, INC. VERIFYNOW PRUTEST by Accumetrics, Inc. — Product Code JOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 2015
Date Received
May 30, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Automated Platelet Aggregation
Device Class
Class II
Regulation Number
864.5700
Review Panel
HE
Submission Type

Other clearances by Accumetrics, Inc.

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  • K012701 — ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - ASA (RPFA-ASA) (June 12, 2002)
  • K013596 — MODIFICATION TO ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - TRAP (RPFA-TRAP) (May 16, 2002)
  • K011337 — ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA) (October 16, 2001)
  • K992531 — ULTEGRA SYSTEM ANALYZER, ULTEGRA SYSTEM RPFA-TRAP TEST CARTIDGES, ULTEGRA SYSTEM (December 20, 1999)

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  • K140893 — CORA (COAGULATION RESONANCE ANALYSIS) SYSTEM WITH PLATELET MAPPING ASSAY (January 3, 2015)
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  • K060489 — DADE PFA-100 PLATELET FUNCTION ANALYZER AND REAGENTS (July 21, 2006)
  • K050265 — CHRONO-LOG WHOLE BLOOD LUMI-AGGREGOMETER, MODEL 700 (October 14, 2005)
  • K051231 — VERIFYNOW-P2Y12 ASSAY (August 5, 2005)