ABUSCREEN(R) ONTRAK(TM) FOR MORPHINE— 510(k) K882496

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K882496 for ABUSCREEN(R) ONTRAK(TM) FOR MORPHINE, Substantially Equivalent on 1988-09-02. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code DJG
Advisory panel: Clinical Toxicology
Date received: 1988-06-17
Decision date: 1988-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montclair, NJ, US

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