PHARMACIA CAP SYSTEM IGE FEIA, MODEL 10-9395-01


Device Classification Name

ige, antigen, antiserum, control

510(k) Number K991945
Device Name PHARMACIA CAP SYSTEM IGE FEIA, MODEL 10-9395-01
Applicant
PHARMACIA & UPJOHN CO.
5094 st. andrews dr.
westervillle, 
OH 
43082

Applicant Contact karen e matis
Correspondent
PHARMACIA & UPJOHN CO.
5094 st. andrews dr.
westervillle, 
OH 
43082

Correspodent Contact karen e matis
Regulation Number 866.5510
Classification Product Code
DGC  
Date Received 06/09/1999
Decision Date 07/28/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No