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510(k) K163274

AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument by Aggredyne, Inc. — Product Code JOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 2017
Date Received
November 21, 2016
Clearance Type
Special
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 Aggredyne, Inc.

  • K181777 — AggreGuide A-100 ADP (March 29, 2019)
  • K122162 — AGGREGUIDE (December 20, 2013)

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)
  • 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)
  • K051231 — VERIFYNOW-P2Y12 ASSAY (August 5, 2005)