Test, Morphine, Over The Counter

Device Code: 6242

Product Code(s): NGI

Device Classification Information

Device Type ID6242
Device NameTest, Morphine, Over The Counter
Regulation DescriptionMorphine Test System.
Regulation Medical SpecialtyToxicology
Review PanelToxicology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(k)
CFR Regulation Number862.3640 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeNGI
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID6242
DeviceTest, Morphine, Over The Counter
Product CodeNGI
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionMorphine Test System.
CFR Regulation Number862.3640 [🔎]
TPLC Last Update: 2019-04-02 21:19:16

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