The following data is part of a premarket notification filed by Abbott Diagnostics with the FDA for Dyna-lyte 2000.
| Device ID | K842786 |
| 510k Number | K842786 |
| Device Name: | DYNA-LYTE 2000 |
| Classification | Electrode, Ion Specific, Potassium |
| Applicant | ABBOTT DIAGNOSTICS 850 MAUDE AVE. Mountain View, CA 94043 |
| Product Code | CEM |
| CFR Regulation Number | 862.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-22 |
| Decision Date | 1984-09-14 |