EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY— 510(k) K053061

Substantially Equivalent

Dade Behring, Inc.

FDA 510(k) clearance K053061 for EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY, Substantially Equivalent on 2006-02-06. Applicant: Dade Behring, Inc..

Clearance details

Applicant: Dade Behring, Inc.
Product code: Code MKW
Advisory panel: Clinical Chemistry
Date received: 2005-10-31
Decision date: 2006-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newark, DE, US

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