PHE/TYR KINETIC UV TEST SET— 510(k) K813449

Name: FDA 510(k) clearance K813449
Creator: U.S. Food and Drug Administration
Published: 1981-12-31

Substantially Equivalent

P-L Biochemicals, Inc.

FDA 510(k) clearance K813449 for PHE/TYR KINETIC UV TEST SET, Substantially Equivalent on 1981-12-31. Applicant: P-L Biochemicals, Inc.. Device class: 2.

Clearance details

Applicant: P-L Biochemicals, Inc.
Product code: Code JNB
Device class: Class 2
Regulation: 21 CFR 862.1555
Advisory panel: Clinical Chemistry
Date received: 1981-12-10
Decision date: 1981-12-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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