ONTRAK TESTSTIK FOR BARBITURATES, ONTRAK TESTSTIK FOR BENZODIAZEPINES— 510(k) K983174

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K983174 for ONTRAK TESTSTIK FOR BARBITURATES, ONTRAK TESTSTIK FOR BENZODIAZEPINES, Substantially Equivalent on 1998-11-18. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code JXM
Advisory panel: Clinical Toxicology
Date received: 1998-09-10
Decision date: 1998-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Branchburg, NJ, US

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