The following data is part of a premarket notification filed by Micromedic Systems with the FDA for Autopak 12 Insulin Test Delivery System.
| Device ID | K792279 |
| 510k Number | K792279 |
| Device Name: | AUTOPAK 12 INSULIN TEST DELIVERY SYSTEM |
| 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 | 1979-11-13 |
| Decision Date | 1979-12-06 |