Flame Photometry, Potassium

Device Code: 399

Product Code(s): JGM

Device Classification Information

Device Type ID399
Device NameFlame Photometry, Potassium
Regulation DescriptionPotassium 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 Number862.1600 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeJGM
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 ID399
DeviceFlame Photometry, Potassium
Product CodeJGM
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionPotassium Test System.
CFR Regulation Number862.1600 [🔎]
TPLC Last Update: 2019-04-02 19:34:03

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