510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K081868Substantially Equivalent

Smart Leish, Model Lgm1-050

U.S. Army Medical Research Institute of Infectious, Fort Detrick MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K081868 is the FDA 510(k) clearance record for SMART LEISH, MODEL LGM1-050, a class I device, cleared for U.S. Army Medical Research Institute of Infectious on under FDA product code OUZ (Nucleic Amplification Assays For The Detection Of Leishmania Nucleic Acids). FDA's definition for product code OUZ reads: "Detection of Leishmania species in skin lesions". FDA records list one 510(k) clearance for U.S. Army Medical Research Institute of Infectious. As of , FDA records show no recalls naming K081868.

Clearance record

Decision date
Received
(1,057 days to decision)
Product code
OUZ Nucleic Amplification Assays For The Detection Of Leishmania Nucleic Acids
Regulation
21 CFR 866.3870
Device class
Class I
Review panel
Microbiology
Applicant
U.S. Army Medical Research Institute of Infectious 1452 Porter St., Fort Detrick MD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OUZ

Trailing 12 months

FDA records hold no clearances under product code OUZ in the trailing twelve months.

FDA records show no clearances under product code OUZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OUZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260