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

Name: FDA 510(k) clearance K041635
Creator: U.S. Food and Drug Administration
Published: 2004-08-16

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.. Device class: 2.

Clearance details

Applicant: Provalis Diagnostics , Ltd.
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 2004-06-16
Decision date: 2004-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, US

Download summary PDF View on FDA.gov ↗

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