N LATEX IGA


Device Classification Name

iga, antigen, antiserum, control

510(k) Number K024038
Device Name N LATEX IGA
Original Applicant
DADE BEHRING, INC.
p.o. box 6101
newark, 
DE 
19714

Original Contact kathleen a dray-lyons
Regulation Number 866.5510
Classification Product Code
CZP  
Date Received 12/06/2002
Decision Date 02/13/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No