Microtome, Ultra

Device Code: 4948

Product Code(s): IDM

Device Classification Information

Device Type ID4948
Device NameMicrotome, Ultra
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 CodeIDM
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4948
DeviceMicrotome, Ultra
Product CodeIDM
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionTissue Processing Equipment.
CFR Regulation Number864.3010 [🔎]
TPLC Last Update: 2019-04-02 20:57:53

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