RAPID DRUGS OF ABUSE SINGLE AND MULTIPLE TEST PANELS— 510(k) K003809

Name: FDA 510(k) clearance K003809
Creator: U.S. Food and Drug Administration
Published: 2001-04-20

Substantially Equivalent

Rapid Diagnostics, Inc.

FDA 510(k) clearance K003809 for RAPID DRUGS OF ABUSE SINGLE AND MULTIPLE TEST PANELS, Substantially Equivalent on 2001-04-20. 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: 2000-12-08
Decision date: 2001-04-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burlingame, CA, US

Download summary PDF View on FDA.gov ↗

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