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510(k) K222438

A-LYTE® Integrated Multisensor (IMT Na K Cl) by Siemens Healthcare Diagnostics, Inc. — Product Code JGS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2023
Date Received
August 12, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Ion Specific, Sodium
Device Class
Class II
Regulation Number
862.1665
Review Panel
CH
Submission Type

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