The following data is part of a premarket notification filed by Fujirebio Diagnostics, Inc. with the FDA for Axsym Cortisol Assay.
| Device ID | K033731 |
| 510k Number | K033731 |
| Device Name: | AXSYM CORTISOL ASSAY |
| Classification | Fluorometric, Cortisol |
| Applicant | FUJIREBIO DIAGNOSTICS, INC. 201 GREAT VALLEY PKWY. Malvern, PA 19355 |
| Contact | Kimberly Peterson |
| Correspondent | Kimberly Peterson FUJIREBIO DIAGNOSTICS, INC. 201 GREAT VALLEY PKWY. Malvern, PA 19355 |
| Product Code | JFT |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1205 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-28 |
| Decision Date | 2004-02-20 |
| Summary: | summary |