PSYCHEMEDICS MICROPLATE EIA FOR AMPHETAMINE— 510(k) K130811

Name: FDA 510(k) clearance K130811
Creator: U.S. Food and Drug Administration
Published: 2013-05-02

Substantially Equivalent

Psychemedics Corp.

FDA 510(k) clearance K130811 for PSYCHEMEDICS MICROPLATE EIA FOR AMPHETAMINE, Substantially Equivalent on 2013-05-02. Applicant: Psychemedics Corp.. Device class: 2.

Clearance details

Applicant: Psychemedics Corp.
Product code: Code DKZ
Device class: Class 2
Regulation: 21 CFR 862.3100
Advisory panel: Clinical Toxicology
Date received: 2013-03-25
Decision date: 2013-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Culver City, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.