The following data is part of a premarket notification filed by Ams with the FDA for Liasys 450.
| Device ID | K113131 |
| 510k Number | K113131 |
| Device Name: | LIASYS 450 |
| Classification | Hexokinase, Glucose |
| Applicant | AMS 17/A VIA E. BARSANTI Guidonia, Rome, IT I-00012 |
| Contact | Stefano Corradi |
| Correspondent | Stefano Corradi AMS 17/A VIA E. BARSANTI Guidonia, Rome, IT I-00012 |
| Product Code | CFR |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | JGS |
| Subsequent Product Code | JJE |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-24 |
| Decision Date | 2012-03-08 |