Radiometric, Fe59, Iron Binding Capacity

Device Code: 555

Product Code(s): JQG

Device Classification Information

Device Type ID555
Device NameRadiometric, Fe59, Iron Binding Capacity
Regulation DescriptionIron-binding Capacity 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 Number862.1415 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeJQG
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 ID555
DeviceRadiometric, Fe59, Iron Binding Capacity
Product CodeJQG
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionIron-binding Capacity Test System.
CFR Regulation Number862.1415 [🔎]
TPLC Last Update: 2019-04-02 18:47:52

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