510(k) K910658— ABUSCREEN ONTRAK FOR METHAMPHETAMINE

Substantially Equivalent

Roche Diagnostic Systems, Inc.

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code DKZ
Advisory panel: Clinical Toxicology
Date received: 1991-02-14
Decision date: 1991-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montclair, NJ, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.