The following data is part of a premarket notification filed by Horiba Instruments, Inc. with the FDA for Modify Electrolyte Analyzer Model Sera-210.
| Device ID | K844806 |
| 510k Number | K844806 |
| Device Name: | MODIFY ELECTROLYTE ANALYZER MODEL SERA-210 |
| Classification | Electrode, Ion Specific, Potassium |
| Applicant | HORIBA INSTRUMENTS, INC. 1021 DURYEA AVE. Irvine, CA 92714 |
| Contact | Tim Scott |
| Correspondent | Tim Scott HORIBA INSTRUMENTS, INC. 1021 DURYEA AVE. Irvine, CA 92714 |
| Product Code | CEM |
| CFR Regulation Number | 862.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-11 |
| Decision Date | 1985-01-08 |