The following data is part of a premarket notification filed by Horiba, Ltd with the FDA for Yumizen C1200, Yumizen C1200 Glucose Hk, Sodium Electrode, Potassium Electrode, Chloride Electrode.
| Device ID | K183375 |
| 510k Number | K183375 |
| Device Name: | Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode |
| Classification | Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
| Applicant | Horiba, Ltd 2 Miyanohigashi, Kisshoin, Minami-ku Kyoto, JP 601-8510 |
| Contact | Naoyuki Nomura |
| Correspondent | Naoyuki Nomura Horiba, Ltd 2 Miyanohigashi, Kisshoin, Minami-ku Kyoto, JP 601-8510 |
| Product Code | JJE |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CFR |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | JGS |
| CFR Regulation Number | 862.2160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-06 |
| Decision Date | 2019-02-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03610230007020 | K183375 | 000 |
| 03610230007013 | K183375 | 000 |
| 03610230009260 | K183375 | 000 |
| 03610230009253 | K183375 | 000 |