COBAS FP TDM CONTROLS— 510(k) K843913

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K843913 for COBAS FP TDM CONTROLS, Substantially Equivalent on 1984-10-30. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code DIF
Advisory panel: Clinical Toxicology
Date received: 1984-10-04
Decision date: 1984-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nutley, NJ, US

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