BIURET (COLORMETRIC), TOTAL PROTEIN— 510(k) K901527

Name: FDA 510(k) clearance K901527
Creator: U.S. Food and Drug Administration
Published: 1990-07-19

Substantially Equivalent

American Research Products Co.

FDA 510(k) clearance K901527 for BIURET (COLORMETRIC), TOTAL PROTEIN, Substantially Equivalent on 1990-07-19. Applicant: American Research Products Co.. Device class: 2.

Clearance details

Applicant: American Research Products Co.
Product code: Code CEK
Device class: Class 2
Regulation: 21 CFR 862.1635
Advisory panel: Clinical Chemistry
Date received: 1990-04-02
Decision date: 1990-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Solon, OH, US

Download summary PDF View on FDA.gov ↗

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