AMEDITECH IMMU TEST DRUG SCREEN PANEL— 510(k) K040092

Name: FDA 510(k) clearance K040092
Creator: U.S. Food and Drug Administration
Published: 2004-03-08

Substantially Equivalent

Ameditech, Inc.

FDA 510(k) clearance K040092 for AMEDITECH IMMU TEST DRUG SCREEN PANEL, Substantially Equivalent on 2004-03-08. Applicant: Ameditech, Inc.. Device class: 2.

Clearance details

Applicant: Ameditech, Inc.
Product code: Code DKZ
Device class: Class 2
Regulation: 21 CFR 862.3100
Advisory panel: Clinical Toxicology
Date received: 2004-01-16
Decision date: 2004-03-08
Decision: Substantially Equivalent
Clearance type: Special
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.