LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600— 510(k) K172232

Name: FDA 510(k) clearance K172232
Creator: U.S. Food and Drug Administration
Published: 2019-06-12

Substantially Equivalent

Ams Diagnostics

FDA 510(k) clearance K172232 for LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600, Substantially Equivalent on 2019-06-12. Applicant: Ams Diagnostics. Device class: 2.

Clearance details

Applicant: Ams Diagnostics
Product code: Code JGS
Device class: Class 2
Regulation: 21 CFR 862.1665
Advisory panel: Clinical Chemistry
Date received: 2017-07-25
Decision date: 2019-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Weston, FL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code JGS

product code JGS

Malfunction: 535
Total: 535

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.