ONTRAK TESTSTIK FOR MORPHINE 2000 (M2K)— 510(k) K990409

Name: FDA 510(k) clearance K990409
Creator: U.S. Food and Drug Administration
Published: 1999-04-15

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K990409 for ONTRAK TESTSTIK FOR MORPHINE 2000 (M2K), Substantially Equivalent on 1999-04-15. Applicant: Roche Diagnostics Corp.. Device class: 2.

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code DMY
Device class: Class 2
Regulation: 21 CFR 862.3640
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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