The following data is part of a premarket notification filed by Immuchem Corp. with the FDA for Covalent Coat Ria Kit.
| Device ID | K822509 |
| 510k Number | K822509 |
| Device Name: | COVALENT COAT RIA KIT |
| Classification | Radioimmunoassay, Immunoreactive Insulin |
| Applicant | IMMUCHEM CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CFP |
| CFR Regulation Number | 862.1405 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-08-20 |
| Decision Date | 1982-09-28 |