510(k) K081868

Device

SMART LEISH, MODEL LGM1-050

Applicant

U.S. ARMY MEDICAL RESEARCH INSTITUTE OF INFECTIOUS

510(k) number

K081868

Product code

OUZ  

Decision

Substantially Equivalent (SESE)

Decision date

2011-05-25

Date received

2008-07-02

Regulation

866.3870

Classification name

Nucleic Amplification Assays For The Detection Of Leishmania Nucleic Acids

Medical specialty

Microbiology

Review panel

Microbiology

Device class

1

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

No