ROCHE ABUSCREEN ONTRAK POS. REF. CONTROL-METHADONE— 510(k) K930844

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K930844 for ROCHE ABUSCREEN ONTRAK POS. REF. CONTROL-METHADONE, Substantially Equivalent on 1994-01-27. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code LAS
Advisory panel: Clinical Toxicology
Date received: 1993-02-18
Decision date: 1994-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Branchburg, NJ, US

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