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FDA 510(k)

SMART LEISH, MODEL LGM1-050

K-Number: K081868 · 2011-05-25

ApplicantU.S. Army Medical Research Institute of Infectious
Decision Date2011-05-25
Product CodeOUZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SMART LEISH, MODEL LGM1-050 is the device name listed in this FDA 510(k) record. The listed applicant is U.S. Army Medical Research Institute of Infectious. It received FDA 510(k) clearance on 2011-05-25 under 510(k) number K081868. The device is classified under product code OUZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMART LEISH, MODEL LGM1-050?

SMART LEISH, MODEL LGM1-050 is a medical device that received FDA 510(k) clearance on 2011-05-25. The listed applicant is U.S. Army Medical Research Institute of Infectious. The 510(k) number is K081868.

When did SMART LEISH, MODEL LGM1-050 receive FDA 510(k) clearance?

SMART LEISH, MODEL LGM1-050 received FDA 510(k) clearance on 2011-05-25, under 510(k) number K081868.

Who is the listed applicant for SMART LEISH, MODEL LGM1-050?

The FDA 510(k) record lists U.S. Army Medical Research Institute of Infectious as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SMART LEISH, MODEL LGM1-050?

The FDA product code for SMART LEISH, MODEL LGM1-050 is OUZ.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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