The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Coat-a-count Insulin Kit.
| Device ID | K821861 |
| 510k Number | K821861 |
| Device Name: | COAT-A-COUNT INSULIN KIT |
| Classification | Radioimmunoassay, Immunoreactive Insulin |
| Applicant | DIAGNOSTIC PRODUCTS 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 | 1982-06-24 |
| Decision Date | 1982-07-08 |