Solution, Formalin-sodium Acetate

Device Code: 4978

Product Code(s): IGB

Device Classification Information

Device Type ID4978
Device NameSolution, Formalin-sodium Acetate
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 CodeIGB
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4978
DeviceSolution, Formalin-sodium Acetate
Product CodeIGB
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionGeneral Purpose Reagent.
CFR Regulation Number864.4010 [🔎]
TPLC Last Update: 2019-04-02 20:58:20

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