AMEDITECH IMMUTEST DRUG SCREEN COC— 510(k) K011814

Name: FDA 510(k) clearance K011814
Creator: U.S. Food and Drug Administration
Published: 2001-10-22

Substantially Equivalent

Ameditech, Inc.

FDA 510(k) clearance K011814 for AMEDITECH IMMUTEST DRUG SCREEN COC, Substantially Equivalent on 2001-10-22. Applicant: Ameditech, Inc.. Device class: 2.

Clearance details

Applicant: Ameditech, Inc.
Product code: Code DIO
Device class: Class 2
Regulation: 21 CFR 862.3250
Advisory panel: Clinical Toxicology
Date received: 2001-06-11
Decision date: 2001-10-22
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.