Lamps, Slide Warming

Device Code: 4961

Product Code(s): IEH

Device Classification Information

Device Type ID4961
Device NameLamps, Slide Warming
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 CodeIEH
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4961
DeviceLamps, Slide Warming
Product CodeIEH
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionTissue Processing Equipment.
CFR Regulation Number864.3010 [🔎]
TPLC Last Update: 2019-04-02 20:58:05

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