AMEDITECH IMMUTEST MULTI-DRUG SCREEN BUP/PPX/COC150— 510(k) K063015

Name: FDA 510(k) clearance K063015
Creator: U.S. Food and Drug Administration
Published: 2006-12-20

Substantially Equivalent

Ameditech, Inc.

FDA 510(k) clearance K063015 for AMEDITECH IMMUTEST MULTI-DRUG SCREEN BUP/PPX/COC150, Substantially Equivalent on 2006-12-20. Applicant: Ameditech, Inc.. Device class: 2.

Clearance details

Applicant: Ameditech, Inc.
Product code: Code DJG
Device class: Class 2
Regulation: 21 CFR 862.3650
Advisory panel: Clinical Toxicology
Date received: 2006-10-02
Decision date: 2006-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, 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.