MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE— 510(k) K983697

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K983697 for MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE, Substantially Equivalent on 1998-12-11. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code DIO
Advisory panel: Clinical Toxicology
Date received: 1998-10-21
Decision date: 1998-12-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Somerville, NJ, US

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