The following data is part of a premarket notification filed by Seradyn Inc. with the FDA for Architect Cortisol Assay.
Device ID | K062204 |
510k Number | K062204 |
Device Name: | ARCHITECT CORTISOL ASSAY |
Classification | Fluorometric, Cortisol |
Applicant | SERADYN INC. 7998 GEORGETOWN RD. SUITE 1000 Indianapolis, IN 46268 -5260 |
Contact | Earl E Knight |
Correspondent | Earl E Knight SERADYN INC. 7998 GEORGETOWN RD. SUITE 1000 Indianapolis, IN 46268 -5260 |
Product Code | JFT |
CFR Regulation Number | 862.1205 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-08-01 |
Decision Date | 2006-09-22 |
Summary: | summary |