MAJOR QUALITY GLUCOSE AND KETONES URINE TEST— 510(k) K870500

Name: FDA 510(k) clearance K870500
Creator: U.S. Food and Drug Administration
Published: 1987-03-06

Substantially Equivalent

American Diagnostic Corp.

FDA 510(k) clearance K870500 for MAJOR QUALITY GLUCOSE AND KETONES URINE TEST, Substantially Equivalent on 1987-03-06. Applicant: American Diagnostic Corp.. Device class: 2.

Clearance details

Applicant: American Diagnostic Corp.
Product code: Code JIL
Device class: Class 2
Regulation: 21 CFR 862.1340
Advisory panel: Clinical Chemistry
Date received: 1987-02-04
Decision date: 1987-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wheaton, IL, US

Download summary PDF View on FDA.gov ↗

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