Protamine Sulphate

Device Code: 2249

Product Code(s): GFT

Device Classification Information

Device Type ID2249
Device NameProtamine Sulphate
Regulation DescriptionHeparin Assay.
Regulation Medical SpecialtyHematology
Review PanelHematology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(k)
CFR Regulation Number864.7525 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeGFT
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2249
DeviceProtamine Sulphate
Product CodeGFT
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionHeparin Assay.
CFR Regulation Number864.7525 [🔎]
TPLC Last Update: 2019-04-02 20:08:22

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