STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAK— 510(k) K063356

Substantially Equivalent

Dade Behring, Inc.

FDA 510(k) clearance K063356 for STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAK, Substantially Equivalent on 2007-03-23. Applicant: Dade Behring, Inc..

Clearance details

Applicant: Dade Behring, Inc.
Product code: Code DAP
Advisory panel: Hematology
Date received: 2006-11-07
Decision date: 2007-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newark, DE, US

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