Sera, Animal And Human

Device Code: 4840

Product Code(s): KIS

Device Classification Information

Device Type ID4840
Device NameSera, Animal And Human
Regulation DescriptionAnimal And Human Sera.
Regulation Medical SpecialtyHematology
Review PanelPathology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number864.2800 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeKIS
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4840
DeviceSera, Animal And Human
Product CodeKIS
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionAnimal And Human Sera.
CFR Regulation Number864.2800 [🔎]
TPLC Last Update: 2019-04-02 20:56:18

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