PHARMACIA IGE EIA

Radioimmunoassay, Immunoglobulins (d, E)

PHARMACIA, INC.

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

Pre-market Notification Details

Device IDK873077
510k NumberK873077
Device Name:PHARMACIA IGE EIA
ClassificationRadioimmunoassay, Immunoglobulins (d, E)
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 CodeJHR  
CFR Regulation Number866.5510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-08-05
Decision Date1987-10-20

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