510(k) K910278— ABUSCREEN(R) ONTRAK(TM) FOR AMPHETAMINE(500 NG/ML)

Substantially Equivalent

Roche Diagnostic Systems, Inc.

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code DKZ
Advisory panel: Clinical Toxicology
Date received: 1991-01-23
Decision date: 1991-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montclair, NJ, US

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