COBAS INTEGRA REAGENT CASSETTES— 510(k) K982382

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K982382 for COBAS INTEGRA REAGENT CASSETTES, Substantially Equivalent on 1998-09-28. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code CFN
Advisory panel: Immunology
Date received: 1998-07-08
Decision date: 1998-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerville, NJ, US

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