ABUSCREEN ONTRAK POSITIVE CONTROL— 510(k) K943999

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K943999 for ABUSCREEN ONTRAK POSITIVE CONTROL, Substantially Equivalent on 1995-01-25. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code DIF
Advisory panel: Clinical Toxicology
Date received: 1994-07-22
Decision date: 1995-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Branchburg, NJ, US

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