510(k) K001421— ONTRAK TESTCUP 501, MODEL 3016633

Substantially Equivalent

Roche Diagnostics Corp.

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code DKZ
Advisory panel: Clinical Toxicology
Date received: 2000-05-05
Decision date: 2000-07-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Indianapolis, IN, US

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