ADVANTAGE THC/COCAINE TEST— 510(k) K003708

Name: FDA 510(k) clearance K003708
Creator: U.S. Food and Drug Administration
Published: 2001-01-22

Substantially Equivalent

Advantage Diagnostics Corp.

FDA 510(k) clearance K003708 for ADVANTAGE THC/COCAINE TEST, Substantially Equivalent on 2001-01-22. Applicant: Advantage Diagnostics Corp.. Device class: 2.

Clearance details

Applicant: Advantage Diagnostics Corp.
Product code: Code DIO
Device class: Class 2
Regulation: 21 CFR 862.3250
Advisory panel: Clinical Toxicology
Date received: 2000-12-01
Decision date: 2001-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redwood City, CA, US

Download summary PDF View on FDA.gov ↗

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