The following data is part of a premarket notification filed by Clinicomp, Inc. with the FDA for Clinicomp Rdms Radionuclide Dispensing Mgmt. Softw.
| Device ID | K850838 |
| 510k Number | K850838 |
| Device Name: | CLINICOMP RDMS RADIONUCLIDE DISPENSING MGMT. SOFTW |
| Classification | Calibrator, Dose, Radionuclide |
| Applicant | CLINICOMP, INC. P.O. BOX 7070 Huntington Woods, MI 48070 |
| Contact | Allen Gigliotti |
| Correspondent | Allen Gigliotti CLINICOMP, INC. P.O. BOX 7070 Huntington Woods, MI 48070 |
| Product Code | KPT |
| CFR Regulation Number | 892.1360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-01 |
| Decision Date | 1985-09-26 |