The following data is part of a premarket notification filed by Nuclear Associates with the FDA for Cal/rad Mark Vi/vdc-505 Dose Calibrator, Model 34-165.
| Device ID | K030066 |
| 510k Number | K030066 |
| Device Name: | CAL/RAD MARK VI/VDC-505 DOSE CALIBRATOR, MODEL 34-165 |
| Classification | Calibrator, Dose, Radionuclide |
| Applicant | NUCLEAR ASSOCIATES 120 ANDREWS RD. Hicksville, NY 11801 |
| Contact | Christine G Castleberry |
| Correspondent | Christine G Castleberry NUCLEAR ASSOCIATES 120 ANDREWS RD. Hicksville, NY 11801 |
| Product Code | KPT |
| CFR Regulation Number | 892.1360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-07 |
| Decision Date | 2003-08-29 |