Dish, Tissue Culture

Device Code: 4845

Product Code(s): KIZ

Device Classification Information

Device Type ID4845
Device NameDish, Tissue Culture
Regulation DescriptionCell And Tissue Culture Supplies And Equipment.
Regulation Medical SpecialtyHematology
Review PanelPathology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number864.2240 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeKIZ
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4845
DeviceDish, Tissue Culture
Product CodeKIZ
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionCell And Tissue Culture Supplies And Equipment.
CFR Regulation Number864.2240 [🔎]
TPLC Last Update: 2019-04-02 20:56:23

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