The following data is part of a premarket notification filed by Micromedic Systems with the FDA for Autopak 12 T3 Ria Test Delivery System.
| Device ID | K791375 |
| 510k Number | K791375 |
| Device Name: | AUTOPAK 12 T3 RIA TEST DELIVERY SYSTEM |
| Classification | Radioimmunoassay, Total Triiodothyronine |
| Applicant | MICROMEDIC SYSTEMS MD |
| Product Code | CDP |
| CFR Regulation Number | 862.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-07-24 |
| Decision Date | 1979-10-11 |