ALCO-SCREEN— 510(k) K121247

Substantially Equivalent

Chematics, Inc.

FDA 510(k) clearance K121247 for ALCO-SCREEN, Substantially Equivalent on 2013-03-22. Applicant: Chematics, Inc.. Device class: 2.

Clearance details

Applicant: Chematics, Inc.
Product code: Code DIC
Device class: Class 2
Regulation: 21 CFR 862.3040
Advisory panel: Clinical Toxicology
Date received: 2012-04-25
Decision date: 2013-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Webster, IN, 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.