The following data is part of a premarket notification filed by Radcal Corp. with the FDA for Radcal Model 4046 Radionuclide Calibr.
| Device ID | K841785 |
| 510k Number | K841785 |
| Device Name: | RADCAL MODEL 4046 RADIONUCLIDE CALIBR |
| Classification | Calibrator, Dose, Radionuclide |
| Applicant | RADCAL CORP. 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 | 1984-04-30 |
| Decision Date | 1984-07-16 |