LIASYS WITH MODELS LIASYS— 510(k) K080468
Substantially EquivalentAms S.R.L. Analyzer Medical System
FDA 510(k) clearance K080468 for LIASYS WITH MODELS LIASYS, Substantially Equivalent on 2008-07-25. Applicant: Ams S.R.L. Analyzer Medical System. Device class: 2.
Clearance details
- Applicant
- Ams S.R.L. Analyzer Medical System
- Product code
- Code CFR
- Device class
- Class 2
- Regulation
- 21 CFR 862.1345
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Guidonia, Rome, IT
Recent devices under product code CFR
view all- K253490 — Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions
- K252357 — Glucose2
- K220134 — cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH
- K191899 — Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions
- K170316 — ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.