The following data is part of a premarket notification filed by Ams Diagnostics with the FDA for Liasys 600 Electrolyte Measurement System, Liasys 600 Creatinine Reagent, Liasys 600.
| Device ID | K172232 |
| 510k Number | K172232 |
| Device Name: | LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine Reagent, LIASYS 600 |
| Classification | Electrode, Ion Specific, Sodium |
| Applicant | AMS Diagnostics 1790 N Commerce Parkway Weston, FL 33326 |
| Contact | Samuel Burgos |
| Correspondent | Samuel Burgos AMS Diagnostics 1790 N Commerce Parkway Weston, FL 33326 |
| Product Code | JGS |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CGX |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | JJE |
| CFR Regulation Number | 862.1665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-25 |
| Decision Date | 2019-06-12 |