ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIAL— 510(k) K111005

Name: FDA 510(k) clearance K111005
Creator: U.S. Food and Drug Administration
Published: 2011-11-15

Substantially Equivalent

Medica Corp.

FDA 510(k) clearance K111005 for ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIAL, Substantially Equivalent on 2011-11-15. Applicant: Medica Corp.. Device class: 2.

Clearance details

Applicant: Medica Corp.
Product code: Code DIC
Device class: Class 2
Regulation: 21 CFR 862.3040
Advisory panel: Clinical Toxicology
Date received: 2011-04-11
Decision date: 2011-11-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford, MA, US

Download summary PDF View on FDA.gov ↗

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