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510(k) K012701

ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - ASA (RPFA-ASA) by Accumetrics, Inc. — Product Code JOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 2002
Date Received
August 14, 2001
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.

  • K141427 — ACCUMETRICS,INC. VERIFYNOW PRUTEST, ACCUMETRICS, INC. VERIFYNOW PRUTEST (July 24, 2015)
  • K051231 — VERIFYNOW-P2Y12 ASSAY (August 5, 2005)
  • K042423 — VERIFYNOW-ASPIRIN ASSAY (October 6, 2004)
  • 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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