COBAS FP REAGENTS FOR CARBAMAZEPINE— 510(k) K850807

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K850807 for COBAS FP REAGENTS FOR CARBAMAZEPINE, Substantially Equivalent on 1985-03-22. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code KLT
Advisory panel: Clinical Toxicology
Date received: 1985-02-27
Decision date: 1985-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Belleville, NJ, US

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