The following data is part of a premarket notification filed by Nichols Institute with the FDA for Adrenocorticotropic/acth Analysis Product.
| Device ID | K926396 |
| 510k Number | K926396 |
| Device Name: | ADRENOCORTICOTROPIC/ACTH ANALYSIS PRODUCT |
| Classification | Radioimmunoassay, Acth |
| Applicant | NICHOLS INSTITUTE 33608 ORTEGA HIGHWAY San Juan Capistrano, CA 92690 |
| Contact | Salvadore Palomares |
| Correspondent | Salvadore Palomares NICHOLS INSTITUTE 33608 ORTEGA HIGHWAY San Juan Capistrano, CA 92690 |
| Product Code | CKG |
| CFR Regulation Number | 862.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-21 |
| Decision Date | 1993-07-27 |