AMERLITE ESTRADIOL-60 ASSAY LAN.0081/2081

Radioimmunoassay, Estradiol

AMERSHAM CORP.

The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Amerlite Estradiol-60 Assay Lan.0081/2081.

Pre-market Notification Details

Device IDK896270
510k NumberK896270
Device Name:AMERLITE ESTRADIOL-60 ASSAY LAN.0081/2081
ClassificationRadioimmunoassay, Estradiol
Applicant AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights,  IL  60005
ContactB Patterson
CorrespondentB Patterson
AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights,  IL  60005
Product CodeCHP  
CFR Regulation Number862.1260 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-10-31
Decision Date1989-12-12

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