ABUSCREEN(R) ONLINE(TM) FOR THC(50/100)(100TEST KT— 510(k) K913414

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K913414 for ABUSCREEN(R) ONLINE(TM) FOR THC(50/100)(100TEST KT, Substantially Equivalent on 1991-09-25. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code LAT
Advisory panel: Clinical Toxicology
Date received: 1991-07-25
Decision date: 1991-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montclair, NJ, US

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