ROCHE COBAS INTEGRA REAGENT CASSETTES— 510(k) K954992

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K954992 for ROCHE COBAS INTEGRA REAGENT CASSETTES, Substantially Equivalent on 1996-01-25. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code CIT
Advisory panel: Clinical Chemistry
Date received: 1995-10-31
Decision date: 1996-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Branchburg, NJ, US

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