ONTRAK TESTCUP M2K, MODEL CAT. 11 1849 8— 510(k) K990399

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K990399 for ONTRAK TESTCUP M2K, MODEL CAT. 11 1849 8, Substantially Equivalent on 1999-04-15. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code DKZ
Advisory panel: Clinical Toxicology
Date received: 1999-02-09
Decision date: 1999-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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