STRATUS CS D-DIMER (DDMR) METHOD (TESTPAK & DILPAK), MODELS CDDMR & CDDMR-D


Device Classification Name

fibrinogen and fibrin split products, antigen, antiserum, control

510(k) Number K022976
Device Name STRATUS CS D-DIMER (DDMR) METHOD (TESTPAK & DILPAK), MODELS CDDMR & CDDMR-D
Original Applicant
DADE BEHRING, INC.
glasgow business community
bldg 500, ms 514 p.o.box 6101
newark, 
DE 
19714 -6101

Original Contact richard m vaught
Regulation Number 864.7320
Classification Product Code
DAP  
Date Received 09/06/2002
Decision Date 01/16/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No