ARCHITECT CORTISOL ASSAY

Fluorometric, Cortisol

SERADYN INC.

The following data is part of a premarket notification filed by Seradyn Inc. with the FDA for Architect Cortisol Assay.

Pre-market Notification Details

Device IDK062204
510k NumberK062204
Device Name:ARCHITECT CORTISOL ASSAY
ClassificationFluorometric, Cortisol
Applicant SERADYN INC. 7998 GEORGETOWN RD. SUITE 1000 Indianapolis,  IN  46268 -5260
ContactEarl E Knight
CorrespondentEarl E Knight
SERADYN INC. 7998 GEORGETOWN RD. SUITE 1000 Indianapolis,  IN  46268 -5260
Product CodeJFT  
CFR Regulation Number862.1205 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-08-01
Decision Date2006-09-22
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.