Nephelometric Method, Lipoproteins

Device Code: 423

Product Code(s): JHQ

Device Classification Information

Device Type ID423
Device NameNephelometric Method, Lipoproteins
Regulation DescriptionLipoprotein 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 Number862.1475 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeJHQ
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID423
DeviceNephelometric Method, Lipoproteins
Product CodeJHQ
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionLipoprotein Test System.
CFR Regulation Number862.1475 [🔎]
TPLC Last Update: 2019-04-02 19:34:25

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