The following data is part of a premarket notification filed by Nuclear Diagnostics, Inc. with the FDA for Spinsep-fe59.
| Device ID | K790133 |
| 510k Number | K790133 |
| Device Name: | SPINSEP-FE59 |
| Classification | Radiometric, Fe59, Iron Binding Capacity |
| Applicant | NUCLEAR DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JQG |
| CFR Regulation Number | 862.1415 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-01-23 |
| Decision Date | 1979-03-02 |