GLYCOSAL II HBA 1C TEST— 510(k) K011933

Substantially Equivalent

Provalis Diagnostics , Ltd.

FDA 510(k) clearance K011933 for GLYCOSAL II HBA 1C TEST, Substantially Equivalent on 2001-11-02. Applicant: Provalis Diagnostics , Ltd..

Clearance details

Applicant: Provalis Diagnostics , Ltd.
Product code: Code LCP
Advisory panel: Hematology
Date received: 2001-06-20
Decision date: 2001-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, US

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