The following data is part of a premarket notification filed by Squibb Diagnostics with the FDA for Radionuclide Infusion System.
| Device ID | K842568 |
| 510k Number | K842568 |
| Device Name: | RADIONUCLIDE INFUSION SYSTEM |
| Classification | Pump, Infusion |
| Applicant | SQUIBB DIAGNOSTICS P.O. BOX 191 New Brunswick, NJ 08903 |
| Contact | Michael P Swiatocha |
| Correspondent | Michael P Swiatocha SQUIBB DIAGNOSTICS P.O. BOX 191 New Brunswick, NJ 08903 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-02 |
| Decision Date | 1984-10-19 |