DHEA-SULFATE DIRECT RIA KIT(125I)

Radioimmunoassay, Dehydroepiandrosterone (free And Sulfate)

Immunalysis Corporation

The following data is part of a premarket notification filed by Immunalysis Corporation with the FDA for Dhea-sulfate Direct Ria Kit(125i).

Pre-market Notification Details

Device IDK811906
510k NumberK811906
Device Name:DHEA-SULFATE DIRECT RIA KIT(125I)
ClassificationRadioimmunoassay, Dehydroepiandrosterone (free And Sulfate)
Applicant Immunalysis Corporation 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJKC  
CFR Regulation Number862.1245 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-07-01
Decision Date1981-07-23

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