The following data is part of a premarket notification filed by Nichols Institute Diagnostics with the FDA for Nichols Advantage Cortisol.
| Device ID | K042689 |
| 510k Number | K042689 |
| Device Name: | NICHOLS ADVANTAGE CORTISOL |
| Classification | Radioimmunoassay, Cortisol |
| Applicant | NICHOLS INSTITUTE DIAGNOSTICS 1311 CALLE BATIDO San Clemente, CA 92673 |
| Contact | Jimmy Wong |
| Correspondent | Jimmy Wong NICHOLS INSTITUTE DIAGNOSTICS 1311 CALLE BATIDO San Clemente, CA 92673 |
| Product Code | CGR |
| CFR Regulation Number | 862.1205 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-29 |
| Decision Date | 2004-12-09 |
| Summary: | summary |