ONLINE DAT BARBITURATES PLUS— 510(k) K043211

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K043211 for ONLINE DAT BARBITURATES PLUS, Substantially Equivalent on 2004-12-29. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code DIS
Advisory panel: Clinical Toxicology
Date received: 2004-11-19
Decision date: 2004-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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