ADVANCED D-DIMER ASSAY— 510(k) K041438

Substantially Equivalent

Dade Behring, Inc.

FDA 510(k) clearance K041438 for ADVANCED D-DIMER ASSAY, Substantially Equivalent on 2004-08-11. Applicant: Dade Behring, Inc..

Clearance details

Applicant: Dade Behring, Inc.
Product code: Code DAP
Advisory panel: Hematology
Date received: 2004-06-01
Decision date: 2004-08-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newark, DE, US

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