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Liasys with Models Liasys

by Ams S.R.L. Analyzer Medical System

510(k) K080468

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK080468 Date25 Jul 2008ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
CFR
Device Class
Class II
Regulation
21 CFR Part 862.1345
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The LIASYS is a random access, computer controlled, counter top, clinical analyzer for clinical chemistry. It provides in vitro diagnostic quantitative measurements for glucose, urea nitrogen, creatinine and AST.

The system can perform 200 tests per hour and has a machine cycle of 18 seconds. It is supplied as a reusable instrument requiring installation according to site specifications and electric current requirements, with accessories such as power supply and computer connectivity. Authorization is based on FDA 510(k) clearance K080468, classified as a Class II device under regulation number 862.1345 for clinical chemistry.

Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the LIASYS analyzer used for?

    The LIASYS analyzer is used for in vitro diagnostic quantitative measurements of glucose, urea nitrogen, creatinine and AST in clinical chemistry, providing random access, computer-controlled testing on a countertop system.

  • How many tests can the LIASYS perform per hour and what is its cycle time?

    The LIASYS can perform 200 tests per hour with a machine cycle of 18 seconds, enabling efficient throughput for clinical chemistry testing in laboratory settings.

  • Is the LIASYS analyzer reusable or single-use, and what does it require for installation?

    The LIASYS is supplied as a reusable instrument requiring installation according to site specifications and electric current requirements, and includes accessories such as a power supply and computer connectivity for operation.