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

Name: FDA 510(k) clearance K990399
Creator: U.S. Food and Drug Administration
Published: 1999-04-15

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.. Device class: 2.

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code DKZ
Device class: Class 2
Regulation: 21 CFR 862.3100
Advisory panel: Clinical Toxicology
Date received: 1999-02-09
Decision date: 1999-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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