The following data is part of a premarket notification filed by Medi Nuclear Corp., Inc. with the FDA for Radionuclide Dose Calibrator.
| Device ID | K813379 |
| 510k Number | K813379 |
| Device Name: | RADIONUCLIDE DOSE CALIBRATOR |
| Classification | Calibrator, Dose, Radionuclide |
| Applicant | MEDI NUCLEAR CORP., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KPT |
| CFR Regulation Number | 892.1360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-12-01 |
| Decision Date | 1982-01-22 |