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510(k) K140893

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

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)

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