Ferricyanide, Glucose

Device Code: 294

Product Code(s): CGD

Device Classification Information

Device Type ID294
Device NameFerricyanide, Glucose
Regulation DescriptionGlucose 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 Number862.1345 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeCGD
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 ID294
DeviceFerricyanide, Glucose
Product CodeCGD
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionGlucose Test System.
CFR Regulation Number862.1345 [🔎]
TPLC Last Update: 2019-04-02 19:32:19

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