COBAS READY AST REAGENT— 510(k) K896238

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K896238 for COBAS READY AST REAGENT, Substantially Equivalent on 1990-02-16. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code CIS
Advisory panel: Clinical Chemistry
Date received: 1989-10-30
Decision date: 1990-02-16
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.