Container, Embedding

Device Code: 5005

Product Code(s): KER

Device Classification Information

Device Type ID5005
Device NameContainer, Embedding
Regulation DescriptionTissue Processing Equipment.
Regulation Medical SpecialtyPathology
Review PanelPathology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number864.3010 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeKER
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5005
DeviceContainer, Embedding
Product CodeKER
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionTissue Processing Equipment.
CFR Regulation Number864.3010 [🔎]
TPLC Last Update: 2019-04-02 20:58:44

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