Test, Methamphetamine, Over The Counter

Device Code: 6241

Product Code(s): NGG

Device Classification Information

Device Type ID6241
Device NameTest, Methamphetamine, Over The Counter
Regulation DescriptionMethamphetamine Test System.
Regulation Medical SpecialtyToxicology
Review PanelToxicology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(k)
CFR Regulation Number862.3610 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeNGG
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID6241
DeviceTest, Methamphetamine, Over The Counter
Product CodeNGG
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionMethamphetamine Test System.
CFR Regulation Number862.3610 [🔎]
Recalls
Manufacturer Recall Class Date Posted
1
Ameditech Inc
III Oct-25-2018
TPLC Last Update: 2019-04-02 21:19:15

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