Cleared Traditional

GLP systems Track

K213486 · Abbott Laboratories · Chemistry
Mar 2022
Decision
132d
Days
Class 2
Risk

About This 510(k) Submission

K213486 is an FDA 510(k) clearance for the GLP systems Track, a Electrode, Ion Specific, Sodium (Class II — Special Controls, product code JGS), submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on March 10, 2022, 132 days after receiving the submission on October 29, 2021. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1665.

Submission Details

510(k) Number K213486 FDA.gov
FDA Decision Cleared SESE
Date Received October 29, 2021
Decision Date March 10, 2022
Days to Decision 132 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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