ONTRAK TESTCARD 9— 510(k) K012396

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K012396 for ONTRAK TESTCARD 9, Substantially Equivalent on 2001-11-05. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code DKZ
Advisory panel: Clinical Toxicology
Date received: 2001-07-27
Decision date: 2001-11-05
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Indianapolis, IN, US

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