The following data is part of a premarket notification filed by Horiba Instruments, Inc. with the FDA for Electrolyte Analyzer Sera-210.
| Device ID | K841424 |
| 510k Number | K841424 |
| Device Name: | ELECTROLYTE ANALYZER SERA-210 |
| Classification | Electrode, Ion Specific, Sodium |
| Applicant | HORIBA INSTRUMENTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JGS |
| CFR Regulation Number | 862.1665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-06 |
| Decision Date | 1984-06-22 |