MICROMEDIC DRUGS OF ABUSE PANEL TEST (9), CATALOG NUMBER 07RD-7062— 510(k) K033566

Name: FDA 510(k) clearance K033566
Creator: U.S. Food and Drug Administration
Published: 2004-05-17

Substantially Equivalent

Rapid Diagnostics, Inc.

FDA 510(k) clearance K033566 for MICROMEDIC DRUGS OF ABUSE PANEL TEST (9), CATALOG NUMBER 07RD-7062, Substantially Equivalent on 2004-05-17. Applicant: Rapid Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Rapid Diagnostics, Inc.
Product code: Code DKZ
Device class: Class 2
Regulation: 21 CFR 862.3100
Advisory panel: Clinical Toxicology
Date received: 2003-11-12
Decision date: 2004-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northridge, CA, US

Download summary PDF View on FDA.gov ↗

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