COBAS-FP REAGENT FOR VALPROIC ACID & CALIBRATORS— 510(k) K891581

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K891581 for COBAS-FP REAGENT FOR VALPROIC ACID & CALIBRATORS, Substantially Equivalent on 1989-08-15. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code LEG
Advisory panel: Clinical Toxicology
Date received: 1989-03-20
Decision date: 1989-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montclair, NJ, US

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