AMERLEX CORTISOL RIA KIT

Radioimmunoassay, Cortisol

AMERSHAM CORP.

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

Pre-market Notification Details

Device IDK800700
510k NumberK800700
Device Name:AMERLEX CORTISOL RIA KIT
ClassificationRadioimmunoassay, Cortisol
Applicant AMERSHAM CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCGR  
CFR Regulation Number862.1205 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-03-28
Decision Date1980-04-16

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