The following data is part of a premarket notification filed by Nichols Institute Diagnostics with the FDA for Nichols Advantage Chemiluminescence Cortisol Immunoassay, Model 62-7005.
| Device ID | K984520 |
| 510k Number | K984520 |
| Device Name: | NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL IMMUNOASSAY, MODEL 62-7005 |
| Classification | Radioimmunoassay, Cortisol |
| Applicant | NICHOLS INSTITUTE DIAGNOSTICS 33051 CALLE AVIADOR San Juan Capistrano, CA 92675 |
| Contact | Jim Wong |
| Correspondent | Jim Wong NICHOLS INSTITUTE DIAGNOSTICS 33051 CALLE AVIADOR San Juan Capistrano, CA 92675 |
| Product Code | CGR |
| CFR Regulation Number | 862.1205 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-21 |
| Decision Date | 1999-02-05 |
| Summary: | summary |