PHARMACIA IGE RIACT

Ige, Antigen, Antiserum, Control

PHARMACIA, INC.

The following data is part of a premarket notification filed by Pharmacia, Inc. with the FDA for Pharmacia Ige Riact.

Pre-market Notification Details

Device IDK881892
510k NumberK881892
Device Name:PHARMACIA IGE RIACT
ClassificationIge, Antigen, Antiserum, Control
Applicant PHARMACIA, INC. 800 CENTENNIAL AVE. Piscataway,  NJ  08854 -3911
ContactAlbert P Mayo
CorrespondentAlbert P Mayo
PHARMACIA, INC. 800 CENTENNIAL AVE. Piscataway,  NJ  08854 -3911
Product CodeDGC  
CFR Regulation Number866.5510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-05-04
Decision Date1988-06-10

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.