Cleared Traditional

i-STAT Alinity System with i-STAT Sodium test

K153357 · Abbott Point of Care, Inc. · Chemistry
Jul 2016
Decision
231d
Days
Class 2
Risk

About This 510(k) Submission

K153357 is an FDA 510(k) clearance for the i-STAT Alinity System with i-STAT Sodium test, a Electrode, Ion Specific, Sodium (Class II — Special Controls, product code JGS), submitted by Abbott Point of Care, Inc. (Princton, US). The FDA issued a Cleared decision on July 8, 2016, 231 days after receiving the submission on November 20, 2015. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1665.

Submission Details

510(k) Number K153357 FDA.gov
FDA Decision Cleared SESE
Date Received November 20, 2015
Decision Date July 08, 2016
Days to Decision 231 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JGS — Electrode, Ion Specific, Sodium
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1665

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