SMART LEISH, MODEL LGM1-050— 510(k) K081868

Name: FDA 510(k) clearance K081868
Creator: U.S. Food and Drug Administration
Published: 2011-05-25

Substantially Equivalent

U.S. Army Medical Research Institute of Infectious

FDA 510(k) clearance K081868 for SMART LEISH, MODEL LGM1-050, Substantially Equivalent on 2011-05-25. Applicant: U.S. Army Medical Research Institute of Infectious. Device class: 1.

Clearance details

Applicant: U.S. Army Medical Research Institute of Infectious
Product code: Code OUZ
Device class: Class 1
Regulation: 21 CFR 866.3870
Advisory panel: Microbiology
Date received: 2008-07-02
Decision date: 2011-05-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Detrick, MD, US

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