COBAS REAGENTS FOR URIC ACID— 510(k) K801243

Name: FDA 510(k) clearance K801243
Creator: U.S. Food and Drug Administration
Published: 1980-06-26

Substantially Equivalent

Roche Analytical Instruments, Inc.

FDA 510(k) clearance K801243 for COBAS REAGENTS FOR URIC ACID, Substantially Equivalent on 1980-06-26. Applicant: Roche Analytical Instruments, Inc.. Device class: 1.

Clearance details

Applicant: Roche Analytical Instruments, Inc.
Product code: Code CDO
Device class: Class 1
Regulation: 21 CFR 862.1775
Advisory panel: Clinical Chemistry
Date received: 1980-05-27
Decision date: 1980-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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