URIC ACID FOR MANUAL/AUTOMATED APPLICATIONS— 510(k) K895821

Name: FDA 510(k) clearance K895821
Creator: U.S. Food and Drug Administration
Published: 1989-12-05

Substantially Equivalent

Catachem, Inc.

FDA 510(k) clearance K895821 for URIC ACID FOR MANUAL/AUTOMATED APPLICATIONS, Substantially Equivalent on 1989-12-05. Applicant: Catachem, Inc.. Device class: 1.

Clearance details

Applicant: Catachem, Inc.
Product code: Code KNK
Device class: Class 1
Regulation: 21 CFR 862.1775
Advisory panel: Clinical Chemistry
Date received: 1989-09-29
Decision date: 1989-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Port Chester, NY, US

Download summary PDF View on FDA.gov ↗

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