ROCHE COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS— 510(k) K972250

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K972250 for ROCHE COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS, Substantially Equivalent on 1997-08-12. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code JFJ
Advisory panel: Clinical Chemistry
Date received: 1997-06-16
Decision date: 1997-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerville, NJ, US

Download summary PDF View on FDA.gov ↗

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