ALCO-SCREEN 02— 510(k) K121256

Substantially Equivalent

Chematics, Inc.

FDA 510(k) clearance K121256 for ALCO-SCREEN 02, Substantially Equivalent on 2012-09-12. 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: 2012-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Webster, IN, US

Download summary PDF View on FDA.gov ↗

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