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

Ige, Antigen, Antiserum, Control

PHARMACIA & UPJOHN CO.

The following data is part of a premarket notification filed by Pharmacia & Upjohn Co. with the FDA for Pharmacia Cap System Ige Feia, Model 10-9395-01.

Pre-market Notification Details

Device IDK991945
510k NumberK991945
Device Name:PHARMACIA CAP SYSTEM IGE FEIA, MODEL 10-9395-01
ClassificationIge, Antigen, Antiserum, Control
Applicant PHARMACIA & UPJOHN CO. 5094 ST. ANDREWS DR. Westervillle,  OH  43082
ContactKaren E Matis
CorrespondentKaren E Matis
PHARMACIA & UPJOHN CO. 5094 ST. ANDREWS DR. Westervillle,  OH  43082
Product CodeDGC  
CFR Regulation Number866.5510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-06-09
Decision Date1999-07-28
Summary:summary

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