The following data is part of a premarket notification filed by Nichols Institute with the FDA for Nichols Institute Diagnostics Dhea-s Chemiluminescence Immunoassay.
| Device ID | K950524 |
| 510k Number | K950524 |
| Device Name: | NICHOLS INSTITUTE DIAGNOSTICS DHEA-S CHEMILUMINESCENCE IMMUNOASSAY |
| Classification | Radioimmunoassay, Dehydroepiandrosterone (free And Sulfate) |
| Applicant | NICHOLS INSTITUTE 33608 ORTEGA HIGHWAY San Juan Capistrano, CA 92690 |
| Contact | Dave D Smith |
| Correspondent | Dave D Smith NICHOLS INSTITUTE 33608 ORTEGA HIGHWAY San Juan Capistrano, CA 92690 |
| Product Code | JKC |
| CFR Regulation Number | 862.1245 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-30 |
| Decision Date | 1995-05-15 |