VERDICT -II THC/COC/OPI/AMP/PCP/BAR/BZO & THC/COC/BAR/BZO; PROFILE -II 7 THC/COC/OPI/AMP/PCP/BAR/BZO— 510(k) K010564

Name: FDA 510(k) clearance K010564
Creator: U.S. Food and Drug Administration
Published: 2001-04-05

Substantially Equivalent

Medtox Diagnostics, Inc.

FDA 510(k) clearance K010564 for VERDICT -II THC/COC/OPI/AMP/PCP/BAR/BZO & THC/COC/BAR/BZO; PROFILE -II 7 THC/COC/OPI/AMP/PCP/BAR/BZO, Substantially Equivalent on 2001-04-05. Applicant: Medtox Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Medtox Diagnostics, Inc.
Product code: Code DKZ
Device class: Class 2
Regulation: 21 CFR 862.3100
Advisory panel: Clinical Toxicology
Date received: 2001-02-26
Decision date: 2001-04-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Burlington, NC, US

Download summary PDF View on FDA.gov ↗

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