Test, Lactic Acid, Over The Counter

Device Code: 6007

Product Code(s): NGD

Device Classification Information

Device Type ID6007
Device NameTest, Lactic Acid, Over The Counter
Regulation DescriptionLactic Acid Test System.
Regulation Medical SpecialtyClinical Chemistry
Review PanelToxicology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(k)
CFR Regulation Number862.1450 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeNGD
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID6007
DeviceTest, Lactic Acid, Over The Counter
Product CodeNGD
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionLactic Acid Test System.
CFR Regulation Number862.1450 [🔎]
TPLC Last Update: 2019-04-02 21:15:58

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