ROCHE UNIMATE FRUCTOSAMINE REAGENT— 510(k) K961674

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K961674 for ROCHE UNIMATE FRUCTOSAMINE REAGENT, Substantially Equivalent on 1996-09-27. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code LCP
Advisory panel: Hematology
Date received: 1996-05-01
Decision date: 1996-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerville, NJ, US

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