G5 I HBA1C TEST, G5 II HBA1C TEST— 510(k) K041635

Substantially Equivalent

Provalis Diagnostics , Ltd.

FDA 510(k) clearance K041635 for G5 I HBA1C TEST, G5 II HBA1C TEST, Substantially Equivalent on 2004-08-16. Applicant: Provalis Diagnostics , Ltd..

Clearance details

Applicant: Provalis Diagnostics , Ltd.
Product code: Code LCP
Advisory panel: Hematology
Date received: 2004-06-16
Decision date: 2004-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, US

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