ROCHE REAGENT FOR C02— 510(k) K911838

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K911838 for ROCHE REAGENT FOR C02, Substantially Equivalent on 1991-07-19. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code CHS
Advisory panel: Clinical Chemistry
Date received: 1991-04-25
Decision date: 1991-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montclair, NJ, US

Download summary PDF View on FDA.gov ↗

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