Resin, Ion-exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity

Device Code: 553

Product Code(s): JQE

Device Classification Information

Device Type ID553
Device NameResin, Ion-exchange, Ascorbic Acid, Colorimetry, 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 CodeJQE
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 ID553
DeviceResin, Ion-exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity
Product CodeJQE
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionIron-binding Capacity Test System.
CFR Regulation Number862.1415 [🔎]
TPLC Last Update: 2019-04-02 19:36:24

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