CORA (COAGULATION RESONANCE ANALYSIS) SYSTEM WITH PLATELET MAPPING ASSAY— 510(k) K140893

Name: FDA 510(k) clearance K140893
Creator: U.S. Food and Drug Administration
Published: 2015-01-03

Substantially Equivalent

Coramed Technologies, LLC

FDA 510(k) clearance K140893 for CORA (COAGULATION RESONANCE ANALYSIS) SYSTEM WITH PLATELET MAPPING ASSAY, Substantially Equivalent on 2015-01-03. Applicant: Coramed Technologies, LLC. Device class: 2.

Clearance details

Applicant: Coramed Technologies, LLC
Product code: Code JOZ
Device class: Class 2
Regulation: 21 CFR 864.5700
Advisory panel: Hematology
Date received: 2014-04-08
Decision date: 2015-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Niles, IL, US

Download summary PDF View on FDA.gov ↗

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