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510(k) K103555

MULTIPLATE 5.0 AGGREGOMETER by Verum Diagnostica GmbH — Product Code JOZ

K103555 is an FDA 510(k) premarket notification submitted by Verum Diagnostica GmbH for the device "MULTIPLATE 5.0 AGGREGOMETER". The FDA issued a decision of Substantially Equivalent on July 27, 2012. The device falls under product code JOZ (System, Automated Platelet Aggregation), a Class II device regulated under 21 CFR 864.5700.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 2012
Date Received
December 3, 2010
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

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  • 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)
  • 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