STRATUS CS D-DIMER— 510(k) K051597

Substantially Equivalent

Dade Behring, Inc.

FDA 510(k) clearance K051597 for STRATUS CS D-DIMER, Substantially Equivalent on 2005-08-17. Applicant: Dade Behring, Inc..

Clearance details

Applicant: Dade Behring, Inc.
Product code: Code DAP
Advisory panel: Hematology
Date received: 2005-06-16
Decision date: 2005-08-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newark, DE, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.