Test, Leukocyte Alkaline Phosphatase

Device Code: 2269

Product Code(s): GHD

Device Classification Information

Device Type ID2269
Device NameTest, Leukocyte Alkaline Phosphatase
Regulation DescriptionLeukocyte Alkaline Phosphatase Test.
Regulation Medical SpecialtyHematology
Review PanelHematology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number864.7660 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeGHD
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2269
DeviceTest, Leukocyte Alkaline Phosphatase
Product CodeGHD
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionLeukocyte Alkaline Phosphatase Test.
CFR Regulation Number864.7660 [🔎]
TPLC Last Update: 2019-04-02 20:08:41

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