PHARMACIA DELFIA NEONATAL HTSH KIT

Radioimmunoassay, Thyroid-stimulating Hormone

PHARMACIA, INC.

The following data is part of a premarket notification filed by Pharmacia, Inc. with the FDA for Pharmacia Delfia Neonatal Htsh Kit.

Pre-market Notification Details

Device IDK905710
510k NumberK905710
Device Name:PHARMACIA DELFIA NEONATAL HTSH KIT
ClassificationRadioimmunoassay, Thyroid-stimulating Hormone
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 CodeJLW  
CFR Regulation Number862.1690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-12-21
Decision Date1991-02-21

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