Chamber, Slide Culture

Device Code: 4844

Product Code(s): KIY

Device Classification Information

Device Type ID4844
Device NameChamber, Slide 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 CodeKIY
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4844
DeviceChamber, Slide Culture
Product CodeKIY
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionCell And Tissue Culture Supplies And Equipment.
CFR Regulation Number864.2240 [🔎]
TPLC Last Update: 2019-04-02 20:56:22

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