Test, Triglycerides, Over The Counter

Device Code: 6010

Product Code(s): NGO

Device Classification Information

Device Type ID6010
Device NameTest, Triglycerides, Over The Counter
Regulation DescriptionTriglyceride Test System.
Regulation Medical SpecialtyClinical Chemistry
Review PanelToxicology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(k)
CFR Regulation Number862.1705 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeNGO
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID6010
DeviceTest, Triglycerides, Over The Counter
Product CodeNGO
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionTriglyceride Test System.
CFR Regulation Number862.1705 [🔎]
TPLC Last Update: 2019-04-02 21:16:00

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