Slide Stainer, Immersion Type

Device Code: 5013

Product Code(s): KIO

Device Classification Information

Device Type ID5013
Device NameSlide Stainer, Immersion Type
Regulation DescriptionAutomated Slide Stainer.
Regulation Medical SpecialtyPathology
Review PanelPathology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number864.3800 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeKIO
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5013
DeviceSlide Stainer, Immersion Type
Product CodeKIO
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionAutomated Slide Stainer.
CFR Regulation Number864.3800 [🔎]
TPLC Last Update: 2019-04-02 20:58:51

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