The following data is part of a premarket notification filed by Micromedic Systems with the FDA for Insulin Autopak.
| Device ID | K781086 |
| 510k Number | K781086 |
| Device Name: | INSULIN AUTOPAK |
| Classification | Radioimmunoassay, Immunoreactive Insulin |
| Applicant | MICROMEDIC SYSTEMS 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 | 1978-06-29 |
| Decision Date | 1978-08-14 |