Electrophoretic Method, Catecholamines

Device Code: 324

Product Code(s): CHT

Device Classification Information

Device Type ID324
Device NameElectrophoretic Method, Catecholamines
Regulation DescriptionCatecholamines (total) Test System.
Regulation Medical SpecialtyClinical Chemistry
Review PanelClinical Chemistry
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number862.1165 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeCHT
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID324
DeviceElectrophoretic Method, Catecholamines
Product CodeCHT
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionCatecholamines (total) Test System.
CFR Regulation Number862.1165 [🔎]
TPLC Last Update: 2019-04-02 19:32:47

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