Cleared Traditional

CORA (COAGULATION RESONANCE ANALYSIS) SYSTEM WITH PLATELET MAPPING ASSAY

K140893 · Coramed Technologies, LLC · Hematology

Jan 2015

Decision

270d

Days

Class 2

Risk

About This 510(k) Submission

K140893 is an FDA 510(k) clearance for the CORA (COAGULATION RESONANCE ANALYSIS) SYSTEM WITH PLATELET MAPPING ASSAY, a System, Automated Platelet Aggregation (Class II — Special Controls, product code JOZ), submitted by Coramed Technologies, LLC (Niles, US). The FDA issued a Cleared decision on January 3, 2015, 270 days after receiving the submission on April 8, 2014. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5700.

Submission Details

510(k) Number	K140893 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 08, 2014
Decision Date	January 03, 2015
Days to Decision	270 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF