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510(k) K011337

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 2001
Date Received
May 2, 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)
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  • K042423 — VERIFYNOW-ASPIRIN ASSAY (October 6, 2004)
  • 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)
  • K992531 — ULTEGRA SYSTEM ANALYZER, ULTEGRA SYSTEM RPFA-TRAP TEST CARTIDGES, ULTEGRA SYSTEM (December 20, 1999)

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  • K060489 — DADE PFA-100 PLATELET FUNCTION ANALYZER AND REAGENTS (July 21, 2006)
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