Assay, Bart's, Hemoglobin

Device Code: 2412

Product Code(s): LGL

Device Classification Information

Device Type ID2412
Device NameAssay, Bart's, Hemoglobin
Regulation DescriptionWhole Blood Hemoglobin Assays.
Regulation Medical SpecialtyHematology
Review PanelHematology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(k)
CFR Regulation Number864.7500 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeLGL
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

Device Type ID2412
DeviceAssay, Bart's, Hemoglobin
Product CodeLGL
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionWhole Blood Hemoglobin Assays.
CFR Regulation Number864.7500 [🔎]
TPLC Last Update: 2019-04-02 20:11:28

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.