ONTRAK TESTSTIK FOR METHAMPHETAMINE, CAT. 1986686— 510(k) K000096

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K000096 for ONTRAK TESTSTIK FOR METHAMPHETAMINE, CAT. 1986686, Substantially Equivalent on 2000-04-26. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code LAF
Advisory panel: Clinical Toxicology
Date received: 2000-01-13
Decision date: 2000-04-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.