COBAS INTEGRA REAGENT CASSETTES FOR ALBUMIN, HBALC AND DIGOXIN— 510(k) K961824

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K961824 for COBAS INTEGRA REAGENT CASSETTES FOR ALBUMIN, HBALC AND DIGOXIN, Substantially Equivalent on 1996-07-23. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code DCF
Advisory panel: Immunology
Date received: 1996-05-10
Decision date: 1996-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerville, NJ, US

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