510(k) K994020— ONTRAK TESTSTIK FOR PCP, CAT. 07 6654 2

Substantially Equivalent

Roche Diagnostics Corp.

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code LCM
Advisory panel: Unknown
Date received: 1999-11-26
Decision date: 2000-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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