Solution, Stabilized Enzyme

Device Code: 2395

Product Code(s): KSK

Device Classification Information

Device Type ID2395
Device NameSolution, Stabilized Enzyme
Regulation DescriptionStabilized Enzyme Solution.
Regulation Medical SpecialtyHematology
Review PanelHematology
Premarket Review Center For Biologics Evaluation & Research (CBER)
Submission Type510(K) Exempt
CFR Regulation Number864.9400 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeKSK
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2395
DeviceSolution, Stabilized Enzyme
Product CodeKSK
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionStabilized Enzyme Solution.
CFR Regulation Number864.9400 [🔎]
TPLC Last Update: 2019-04-02 20:11:06

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