ONTRAK TESTSTIK 2 FOR COCAINE/THC, CAT. 1118579— 510(k) K994164

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K994164 for ONTRAK TESTSTIK 2 FOR COCAINE/THC, CAT. 1118579, Substantially Equivalent on 2000-04-13. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code LDJ
Advisory panel: Clinical Toxicology
Date received: 1999-12-09
Decision date: 2000-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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