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510(k) K181777

AggreGuide A-100 ADP by Aggredyne, Inc. — Product Code JOZ

K181777 is an FDA 510(k) premarket notification submitted by Aggredyne, Inc. for the device "AggreGuide A-100 ADP". The FDA issued a decision of Substantially Equivalent on March 29, 2019. The device falls under product code JOZ (System, Automated Platelet Aggregation), a Class II device regulated under 21 CFR 864.5700. Aggredyne, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 2019
Date Received
July 3, 2018
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 Aggredyne, Inc.

  • K163274 — AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument (April 5, 2017)
  • 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)
  • 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)
  • K051231 — VERIFYNOW-P2Y12 ASSAY (August 5, 2005)

FDA data resources