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510(k) K051231

VERIFYNOW-P2Y12 ASSAY by Accumetrics, Inc. — Product Code JOZ

K051231 is an FDA 510(k) premarket notification submitted by Accumetrics, Inc. for the device "VERIFYNOW-P2Y12 ASSAY". The FDA issued a decision of Substantially Equivalent on August 5, 2005. The device falls under product code JOZ (System, Automated Platelet Aggregation), a Class II device regulated under 21 CFR 864.5700. Accumetrics, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 5, 2005
Date Received
May 13, 2005
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)
  • 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)
  • 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)

Other clearances for product code JOZ

  • K191364 — T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS (February 14, 2020)
  • K181777 — AggreGuide A-100 ADP (March 29, 2019)
  • K163274 — AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument (April 5, 2017)
  • K161329 — Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 (December 2, 2016)
  • K141427 — ACCUMETRICS,INC. VERIFYNOW PRUTEST, ACCUMETRICS, INC. VERIFYNOW PRUTEST (July 24, 2015)
  • K140893 — CORA (COAGULATION RESONANCE ANALYSIS) SYSTEM WITH PLATELET MAPPING ASSAY (January 3, 2015)
  • K122162 — AGGREGUIDE (December 20, 2013)
  • K103555 — MULTIPLATE 5.0 AGGREGOMETER (July 27, 2012)
  • K060489 — DADE PFA-100 PLATELET FUNCTION ANALYZER AND REAGENTS (July 21, 2006)
  • K050265 — CHRONO-LOG WHOLE BLOOD LUMI-AGGREGOMETER, MODEL 700 (October 14, 2005)

FDA data resources