510(k) K222438
K222438 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics, Inc. for the device "A-LYTE® Integrated Multisensor (IMT Na K Cl)". The FDA issued a decision of Substantially Equivalent on July 25, 2023. The device falls under product code JGS (Electrode, Ion Specific, Sodium), a Class II device regulated under 21 CFR 862.1665. Siemens Healthcare Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
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