510(k) K081868
K081868 is an FDA 510(k) premarket notification submitted by U.S. Army Medical Research Institute of Infectious for the device "SMART LEISH, MODEL LGM1-050". The FDA issued a decision of Substantially Equivalent on May 25, 2011. The device falls under product code OUZ (Nucleic Amplification Assays For The Detection Of Leishmania Nucleic Acids), a Class I device regulated under 21 CFR 866.3870.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 25, 2011
- Date Received
- July 2, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Nucleic Amplification Assays For The Detection Of Leishmania Nucleic Acids
- Device Class
- Class I
- Regulation Number
- 866.3870
- Review Panel
- MI
- Submission Type
Detection of Leishmania species in skin lesions.