A-LYTE® Integrated Multisensor (IMT Na K Cl)
FDA 510(k) K222438 · Siemens Healthcare Diagnostics, Inc.
510(k) numberK222438
Submission
- Device name
- A-LYTE® Integrated Multisensor (IMT Na K Cl)
- Applicant
- Siemens Healthcare Diagnostics, Inc.
Tarrytown, NY, US - Received
- August 12, 2022
- Decision date
- July 25, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JGS – Electrode, Ion Specific, Sodium
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1665
- Specialty
- Clinical Chemistry
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Questions and answers
When was A-LYTE® Integrated Multisensor (IMT Na K Cl) cleared by the FDA?
A-LYTE® Integrated Multisensor (IMT Na K Cl) (K222438) received a 510(k) decision of Substantially Equivalent on July 25, 2023, 347 days after the submission was received.
What is the product code of K222438?
The FDA product code is JGS – Electrode, Ion Specific, Sodium, a Class II (moderate risk) device regulated under 21 CFR 862.1665.