EZ-SCREEN: AMPHETAMINES— 510(k) K905700

Name: FDA 510(k) clearance K905700
Creator: U.S. Food and Drug Administration
Published: 1991-01-15

Substantially Equivalent

Environmental Diagnostics, Inc.

FDA 510(k) clearance K905700 for EZ-SCREEN: AMPHETAMINES, Substantially Equivalent on 1991-01-15. Applicant: Environmental Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Environmental Diagnostics, Inc.
Product code: Code DKZ
Device class: Class 2
Regulation: 21 CFR 862.3100
Advisory panel: Clinical Toxicology
Date received: 1990-12-20
Decision date: 1991-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burlington, NC, 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.