PHADEBACT ETEC-LT TEST

Antisera, All Types, Escherichia Coli

PHARMACIA, INC.

The following data is part of a premarket notification filed by Pharmacia, Inc. with the FDA for Phadebact Etec-lt Test.

Pre-market Notification Details

Device IDK874288
510k NumberK874288
Device Name:PHADEBACT ETEC-LT TEST
ClassificationAntisera, All Types, Escherichia Coli
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 CodeGNA  
CFR Regulation Number866.3255 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-10-20
Decision Date1988-09-02

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