UNICAP THYROID PEROXIDASE IGG

System, Test, Thyroid Autoantibody

PHARMACIA & UPJOHN CO.

The following data is part of a premarket notification filed by Pharmacia & Upjohn Co. with the FDA for Unicap Thyroid Peroxidase Igg.

Pre-market Notification Details

Device IDK981930
510k NumberK981930
Device Name:UNICAP THYROID PEROXIDASE IGG
ClassificationSystem, Test, Thyroid Autoantibody
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 CodeJZO  
CFR Regulation Number866.5870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-05-01
Decision Date1998-07-07
Summary:summary

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