Pointe Scientific Cocaine Metabolite Enzyme Immunoassay— 510(k) K191638

Name: FDA 510(k) clearance K191638
Creator: U.S. Food and Drug Administration
Published: 2020-03-12

Substantially Equivalent

Medtest DX

FDA 510(k) clearance K191638 for Pointe Scientific Cocaine Metabolite Enzyme Immunoassay, Substantially Equivalent on 2020-03-12. Applicant: Medtest DX. Device class: 2.

Clearance details

Applicant: Medtest DX
Product code: Code DIO
Device class: Class 2
Regulation: 21 CFR 862.3250
Advisory panel: Clinical Toxicology
Date received: 2019-06-19
Decision date: 2020-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lincoln Park, MI, US

Download summary PDF View on FDA.gov ↗

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