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510(k) Data Aggregation
K Number
K003557Device Name
ACON THC ONE STEP MARIJUANA TEST STRIP(URINE);ACON THC ONE STEP MARIJUANA TEST DEVICE (URINE)Manufacturer
Date Cleared
2001-03-15
(118 days)
Product Code
Regulation Number
862.3870Type
TraditionalPanel
ToxicologyReference & Predicate Devices
N/A
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Device Name :
ACON THC ONE STEP MARIJUANA TEST STRIP(URINE);ACON THC ONE STEP MARIJUANA TEST DEVICE (URINE)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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Device Description
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