i-STAT Alinity System with i-STAT Sodium test— 510(k) K153357

Clearance details

Applicant

Abbott Point of Care, Inc.

Product code

Code JGS

Device class

Class 2

Regulation

21 CFR 862.1665

Advisory panel

Clinical Chemistry

Date received

2015-11-20

Decision date

2016-07-08

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Princton, NJ, US

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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 →