COBAS FP REAGENT APPLICATION FOR FREE VALPROIC ACID— 510(k) K953224

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K953224 for COBAS FP REAGENT APPLICATION FOR FREE VALPROIC ACID, Substantially Equivalent on 1995-10-30. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code LEG
Advisory panel: Clinical Toxicology
Date received: 1995-06-13
Decision date: 1995-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Branchburg, NJ, US

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