ABUSCREEN ONTRAK FOR THC— 510(k) K904856

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K904856 for ABUSCREEN ONTRAK FOR THC, Substantially Equivalent on 1990-12-13. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code LDJ
Advisory panel: Clinical Toxicology
Date received: 1990-10-29
Decision date: 1990-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montclair, NJ, US

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