ABUSCREEN(R) ONTRAK(TM) FOR COCAINE— 510(k) K881815

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K881815 for ABUSCREEN(R) ONTRAK(TM) FOR COCAINE, Substantially Equivalent on 1988-07-29. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code DIO
Advisory panel: Clinical Toxicology
Date received: 1988-04-28
Decision date: 1988-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montclair, NJ, US

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