COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS— 510(k) K963292

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K963292 for COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS, Substantially Equivalent on 1996-10-31. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code CIC
Advisory panel: Clinical Chemistry
Date received: 1996-08-21
Decision date: 1996-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerville, NJ, US

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