ROCHE STANDARDS FOR URIC ACID— 510(k) K843112

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K843112 for ROCHE STANDARDS FOR URIC ACID, Substantially Equivalent on 1984-09-13. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code JIT
Advisory panel: Clinical Chemistry
Date received: 1984-08-07
Decision date: 1984-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.