epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test— 510(k) K171247

Substantially Equivalent

Epocal, Inc.

FDA 510(k) clearance K171247 for epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test, Substantially Equivalent on 2018-01-17. Applicant: Epocal, Inc..

Clearance details

Applicant: Epocal, Inc.
Product code: Code CDS
Advisory panel: Clinical Chemistry
Date received: 2017-04-28
Decision date: 2018-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ottawa, CA

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