The following data is part of a premarket notification filed by Abbott Diagnostics with the FDA for Fluorometer, General Use.
| Device ID | K830624 |
| 510k Number | K830624 |
| Device Name: | FLUOROMETER, GENERAL USE |
| Classification | Fluorometer, For Clinical Use |
| Applicant | ABBOTT DIAGNOSTICS 850 MAUDE AVE. Mountain View, CA 94043 |
| Product Code | KHO |
| CFR Regulation Number | 862.2560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-02-28 |
| Decision Date | 1983-04-05 |