The following data is part of a premarket notification filed by Abbott Diagnostics with the FDA for Model Am 721 Electrolyte Analyzer.
| Device ID | K810135 |
| 510k Number | K810135 |
| Device Name: | MODEL AM 721 ELECTROLYTE ANALYZER |
| Classification | Electrode, Ion Specific, Sodium |
| Applicant | ABBOTT DIAGNOSTICS 850 MAUDE AVE. Mountain View, CA 94043 |
| Product Code | JGS |
| CFR Regulation Number | 862.1665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-01-21 |
| Decision Date | 1981-02-10 |