GLYCOSAL HBA1C TEST— 510(k) K001392

Name: FDA 510(k) clearance K001392
Creator: U.S. Food and Drug Administration
Published: 2000-08-21

Substantially Equivalent

Provalis Diagnostics , Ltd.

FDA 510(k) clearance K001392 for GLYCOSAL HBA1C TEST, Substantially Equivalent on 2000-08-21. 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: 2000-05-03
Decision date: 2000-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.