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510(k) K140893

CORA (COAGULATION RESONANCE ANALYSIS) SYSTEM WITH PLATELET MAPPING ASSAY by Coramed Technologies, LLC — Product Code JOZ

K140893 is an FDA 510(k) premarket notification submitted by Coramed Technologies, LLC for the device "CORA (COAGULATION RESONANCE ANALYSIS) SYSTEM WITH PLATELET MAPPING ASSAY". The FDA issued a decision of Substantially Equivalent on January 3, 2015. The device falls under product code JOZ (System, Automated Platelet Aggregation), a Class II device regulated under 21 CFR 864.5700. Coramed Technologies, LLC has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 2015
Date Received
April 8, 2014
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 Coramed Technologies, LLC

  • K150041 — CORA (Coagulation Resonance Analysis) System (June 26, 2015)

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)
  • 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