TOTAL ESTRIOL RIA KIT

Radioimmunoassay, Estriol

AMERSHAM CORP.

The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Total Estriol Ria Kit.

Pre-market Notification Details

Device IDK800036
510k NumberK800036
Device Name:TOTAL ESTRIOL RIA KIT
ClassificationRadioimmunoassay, Estriol
Applicant AMERSHAM CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCGI  
CFR Regulation Number862.1265 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-01-07
Decision Date1980-01-21

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