ROCHE REAGENT FOR BUN— 510(k) K954000

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K954000 for ROCHE REAGENT FOR BUN, Substantially Equivalent on 1995-10-25. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code CDQ
Advisory panel: Clinical Chemistry
Date received: 1995-08-25
Decision date: 1995-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Branchburg, NJ, US

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