System, Test, Sodium, Enzymatic Method

Device Code: 623

Product Code(s): MZU

Device Classification Information

Device Type ID623
Device NameSystem, Test, Sodium, Enzymatic Method
Regulation DescriptionSodium Test System.
Regulation Medical SpecialtyClinical Chemistry
Review PanelClinical Chemistry
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(k)
CFR Regulation Number862.1665 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeMZU
GMP ExemptNo
Summary MRIneligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Program

Recognized Standards

Total Product Life Cycle

Device Type ID623
DeviceSystem, Test, Sodium, Enzymatic Method
Product CodeMZU
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionSodium Test System.
CFR Regulation Number862.1665 [🔎]
TPLC Last Update: 2019-04-02 19:37:34

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