Solution, Carnoy's

Device Code: 4984

Product Code(s): IGM

Device Classification Information

Device Type ID4984
Device NameSolution, Carnoy's
Regulation DescriptionGeneral Purpose Reagent.
Regulation Medical SpecialtyPathology
Review PanelPathology
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 CodeIGM
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4984
DeviceSolution, Carnoy's
Product CodeIGM
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionGeneral Purpose Reagent.
CFR Regulation Number864.4010 [🔎]
TPLC Last Update: 2019-04-02 20:58:26

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