COBAS STANDARDS FOR GLUCOSE & BUN— 510(k) K831030

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K831030 for COBAS STANDARDS FOR GLUCOSE & BUN, Substantially Equivalent on 1983-05-09. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code JIX
Advisory panel: Clinical Chemistry
Date received: 1983-03-30
Decision date: 1983-05-09
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.