Strip, Test Isoniazid

Device Code: 6288

Product Code(s): MIG

Device Classification Information

Device Type ID6288
Device NameStrip, Test Isoniazid
Review PanelToxicology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(k)
FDA Device ClassificationClass Unclassified Medical Device
Product CodeMIG
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID6288
DeviceStrip, Test Isoniazid
Product CodeMIG
TPLC Last Update: 2019-04-02 21:19:54

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