Oil, Clearing

Device Code: 2471

Product Code(s): IJZ

Device Classification Information

Device Type ID2471
Device NameOil, Clearing
Regulation DescriptionGeneral Purpose Reagent.
Regulation Medical SpecialtyPathology
Review PanelHematology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number864.4010 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeIJZ
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2471
DeviceOil, Clearing
Product CodeIJZ
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionGeneral Purpose Reagent.
CFR Regulation Number864.4010 [🔎]
TPLC Last Update: 2019-04-02 20:12:58

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