Acid, Ferric Ion-sulfuric, Cholesterol

Device Code: 310

Product Code(s): CHD

Device Classification Information

Device Type ID310
Device NameAcid, Ferric Ion-sulfuric, Cholesterol
Regulation DescriptionCholesterol (total) Test System.
Regulation Medical SpecialtyClinical Chemistry
Review PanelClinical Chemistry
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number862.1175 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeCHD
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID310
DeviceAcid, Ferric Ion-sulfuric, Cholesterol
Product CodeCHD
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionCholesterol (total) Test System.
CFR Regulation Number862.1175 [🔎]
TPLC Last Update: 2019-04-02 19:32:34

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