ABUSCREEN ONTRAK FOR COCAINE (200NG/ML)— 510(k) K905730

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K905730 for ABUSCREEN ONTRAK FOR COCAINE (200NG/ML), Substantially Equivalent on 1991-01-15. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code KLN
Advisory panel: Clinical Toxicology
Date received: 1990-12-24
Decision date: 1991-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montclair, NJ, US

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