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 |