510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K080468Substantially Equivalent

Liasys with Models Liasys

Ams S.r.l. Analyzer Medical System, Guidonia, Rome, IT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K080468 is the FDA 510(k) clearance record for LIASYS WITH MODELS LIASYS, a class II device, cleared for Ams S.R.L. Analyzer Medical System on under FDA product code CFR (Hexokinase, Glucose). FDA records list one 510(k) clearance for Ams S.R.L. Analyzer Medical System. As of , FDA records show no recalls naming K080468.

Clearance record

Decision date
Received
(155 days to decision)
Product code
CFR Hexokinase, Glucose
Regulation
21 CFR 862.1345
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Ams S.R.L. Analyzer Medical System 17/A Via E. Barsanti, Guidonia, Rome, IT
510(k) summary
Statement
Third party review
No

Clearances, product code CFR

Trailing 12 months
1 clearance under product code CFR in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CFR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260