DHEA-S

Radioimmunoassay, Dehydroepiandrosterone (free And Sulfate)

KMI DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Kmi Diagnostics, Inc. with the FDA for Dhea-s.

Pre-market Notification Details

Device IDK973897
510k NumberK973897
Device Name:DHEA-S
ClassificationRadioimmunoassay, Dehydroepiandrosterone (free And Sulfate)
Applicant KMI DIAGNOSTICS, INC. 818 51ST AVE., N.E. SUITE 101 Minneapolis,  MN  55421
ContactMark A Kowal
CorrespondentMark A Kowal
KMI DIAGNOSTICS, INC. 818 51ST AVE., N.E. SUITE 101 Minneapolis,  MN  55421
Product CodeJKC  
CFR Regulation Number862.1245 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-10-14
Decision Date1997-11-13

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