AMEDITECH DRUGSMARTCUP— 510(k) K053175

Substantially Equivalent

Ameditech, Inc.

FDA 510(k) clearance K053175 for AMEDITECH DRUGSMARTCUP, Substantially Equivalent on 2005-12-08. 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: 2005-11-14
Decision date: 2005-12-08
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.