LINEAR ENZYMATIC URIC ACID SYSTEM— 510(k) K843938

Name: FDA 510(k) clearance K843938
Creator: U.S. Food and Drug Administration
Published: 1984-10-30

Substantially Equivalent

Simmler, Inc.

FDA 510(k) clearance K843938 for LINEAR ENZYMATIC URIC ACID SYSTEM, Substantially Equivalent on 1984-10-30. Applicant: Simmler, Inc.. Device class: 1.

Clearance details

Applicant: Simmler, Inc.
Product code: Code KNK
Device class: Class 1
Regulation: 21 CFR 862.1775
Advisory panel: Clinical Chemistry
Date received: 1984-10-09
Decision date: 1984-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

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