STRATUS CS D-DIMER (DDMR) METHOD (TESTPAK & DILPAK), MODELS CDDMR & CDDMR-D— 510(k) K022976

Substantially Equivalent

Dade Behring, Inc.

FDA 510(k) clearance K022976 for STRATUS CS D-DIMER (DDMR) METHOD (TESTPAK & DILPAK), MODELS CDDMR & CDDMR-D, Substantially Equivalent on 2003-01-16. Applicant: Dade Behring, Inc..

Clearance details

Applicant: Dade Behring, Inc.
Product code: Code DAP
Advisory panel: Hematology
Date received: 2002-09-06
Decision date: 2003-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newark, DE, US

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