Electrophoretic, Lactate Dehydrogenase Isoenzymes

Device Code: 281

Product Code(s): CFE

Device Classification Information

Device Type ID281
Device NameElectrophoretic, Lactate Dehydrogenase Isoenzymes
Regulation DescriptionLactate Dehydrogenase Isoenzymes 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 Number862.1445 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeCFE
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

Device Type ID281
DeviceElectrophoretic, Lactate Dehydrogenase Isoenzymes
Product CodeCFE
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionLactate Dehydrogenase Isoenzymes Test System.
CFR Regulation Number862.1445 [🔎]
TPLC Last Update: 2019-04-02 19:32:06

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