EMIT II PLUS ECSTASY ASSAY— 510(k) K043028

Substantially Equivalent

Dade Behring, Inc.

FDA 510(k) clearance K043028 for EMIT II PLUS ECSTASY ASSAY, Substantially Equivalent on 2005-01-07. Applicant: Dade Behring, Inc..

Clearance details

Applicant: Dade Behring, Inc.
Product code: Code DKZ
Advisory panel: Clinical Toxicology
Date received: 2004-11-03
Decision date: 2005-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newark, DE, US

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