FRUCTOSAMINE TEST (ROCHE)— 510(k) K854010

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K854010 for FRUCTOSAMINE TEST (ROCHE), Substantially Equivalent on 1987-12-22. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code LCP
Advisory panel: Hematology
Date received: 1985-09-30
Decision date: 1987-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montclair, NJ, US

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