The following data is part of a premarket notification filed by Damon Corp. with the FDA for Adrenocorticotropin Radio-immunoassay.
| Device ID | K831826 |
| 510k Number | K831826 |
| Device Name: | ADRENOCORTICOTROPIN RADIO-IMMUNOASSAY |
| Classification | Radioimmunoassay, Acth |
| Applicant | DAMON CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CKG |
| CFR Regulation Number | 862.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-06-07 |
| Decision Date | 1983-07-18 |