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

Substantially Equivalent

Ams Diagnostics

Clearance details

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

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.