Titrimetric, Magnesium

Device Code: 287

Product Code(s): CFO

Device Classification Information

Device Type ID287
Device NameTitrimetric, Magnesium
Regulation DescriptionMagnesium 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 Number862.1495 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeCFO
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Program

Recognized Standards

Total Product Life Cycle

Device Type ID287
DeviceTitrimetric, Magnesium
Product CodeCFO
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionMagnesium Test System.
CFR Regulation Number862.1495 [🔎]
TPLC Last Update: 2019-04-02 19:32:12

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