Cleared Traditional

A-LYTE? Integrated Multisensor (IMT Na K Cl)

K222438 · Siemens Healthcare Diagnostics, Inc. · Chemistry
Jul 2023
Decision
347d
Days
Class 2
Risk

About This 510(k) Submission

K222438 is an FDA 510(k) clearance for the A-LYTE? Integrated Multisensor (IMT Na K Cl), a Electrode, Ion Specific, Sodium (Class II — Special Controls, product code JGS), submitted by Siemens Healthcare Diagnostics, Inc. (New York, US). The FDA issued a Cleared decision on July 25, 2023, 347 days after receiving the submission on August 12, 2022. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1665.

Submission Details

510(k) Number K222438 FDA.gov
FDA Decision Cleared SESE
Date Received August 12, 2022
Decision Date July 25, 2023
Days to Decision 347 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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