BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER— 510(k) K092849

Name: FDA 510(k) clearance K092849
Creator: U.S. Food and Drug Administration
Published: 2010-03-30

Substantially Equivalent

Epocal, Inc.

FDA 510(k) clearance K092849 for BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER, Substantially Equivalent on 2010-03-30. Applicant: Epocal, Inc.. Device class: 2.

Clearance details

Applicant: Epocal, Inc.
Product code: Code CEM
Device class: Class 2
Regulation: 21 CFR 862.1600
Advisory panel: Clinical Chemistry
Date received: 2009-09-16
Decision date: 2010-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ottawa, CA

Download summary PDF View on FDA.gov ↗

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