URIC ACID REAGENT (PROCEDURE NUMBER 686)— 510(k) K893416

Name: FDA 510(k) clearance K893416
Creator: U.S. Food and Drug Administration
Published: 1989-06-23

Substantially Equivalent

Sigma Chemical Co.

FDA 510(k) clearance K893416 for URIC ACID REAGENT (PROCEDURE NUMBER 686), Substantially Equivalent on 1989-06-23. Applicant: Sigma Chemical Co.. Device class: 1.

Clearance details

Applicant: Sigma Chemical Co.
Product code: Code KNK
Device class: Class 1
Regulation: 21 CFR 862.1775
Advisory panel: Clinical Chemistry
Date received: 1989-05-02
Decision date: 1989-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

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