The following data is part of a premarket notification filed by Horiba Instruments, Inc. with the FDA for Electrolyte Analyzer Sera-252.
| Device ID | K853405 |
| 510k Number | K853405 |
| Device Name: | ELECTROLYTE ANALYZER SERA-252 |
| Classification | Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph |
| 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 | CHL |
| CFR Regulation Number | 862.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-12 |
| Decision Date | 1985-12-04 |