CORTISOL ENHANCED LUMINESCENCE ASSAY KIT

Radioimmunoassay, Cortisol

AMERSHAM CORP.

The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Cortisol Enhanced Luminescence Assay Kit.

Pre-market Notification Details

Device IDK880687
510k NumberK880687
Device Name:CORTISOL ENHANCED LUMINESCENCE ASSAY KIT
ClassificationRadioimmunoassay, Cortisol
Applicant AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights,  IL  60005
ContactJan L Zorn
CorrespondentJan L Zorn
AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights,  IL  60005
Product CodeCGR  
CFR Regulation Number862.1205 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-02-22
Decision Date1988-03-24

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