The following data is part of a premarket notification filed by Inter Science Institute with the FDA for Insulin Ria Module.
| Device ID | K771947 |
| 510k Number | K771947 |
| Device Name: | INSULIN RIA MODULE |
| Classification | Radioimmunoassay, Immunoreactive Insulin |
| Applicant | INTER SCIENCE INSTITUTE 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 | 1977-10-17 |
| Decision Date | 1978-01-20 |