Microtome, Accessories

Device Code: 4947

Product Code(s): IDL

Device Classification Information

Device Type ID4947
Device NameMicrotome, Accessories
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 CodeIDL
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4947
DeviceMicrotome, Accessories
Product CodeIDL
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionTissue Processing Equipment.
CFR Regulation Number864.3010 [🔎]
Device Problems
Mechanical Jam
1
Total Device Problems 1
TPLC Last Update: 2019-04-02 20:57:53

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