MODIFICATION TO THE EMIT II PLUS COCAINE METABOLITE ASSAY— 510(k) K011162

Substantially Equivalent

Syva Co., Dade Behring, Inc.

FDA 510(k) clearance K011162 for MODIFICATION TO THE EMIT II PLUS COCAINE METABOLITE ASSAY, Substantially Equivalent on 2001-05-02. Applicant: Syva Co., Dade Behring, Inc..

Clearance details

Applicant: Syva Co., Dade Behring, Inc.
Product code: Code DIO
Advisory panel: Clinical Toxicology
Date received: 2001-04-16
Decision date: 2001-05-02
Decision: Substantially Equivalent
Clearance type: Special
Location: San Jose, CA, US

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