The following data is part of a premarket notification filed by Ams S.r.l. Analyzer Medical System with the FDA for Liasys With Models Liasys.
| Device ID | K080468 |
| 510k Number | K080468 |
| Device Name: | LIASYS WITH MODELS LIASYS |
| Classification | Hexokinase, Glucose |
| Applicant | AMS S.R.L. ANALYZER MEDICAL SYSTEM 17/A VIA E. BARSANTI Guidonia (rome), IT I-00012 |
| Contact | Stefano Corradi |
| Correspondent | Stefano Corradi AMS S.R.L. ANALYZER MEDICAL SYSTEM 17/A VIA E. BARSANTI Guidonia (rome), IT I-00012 |
| Product Code | CFR |
| Subsequent Product Code | CDN |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CGX |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | CIT |
| 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 | 2008-02-21 |
| Decision Date | 2008-07-25 |