SMART LEISH, MODEL LGM1-050
FDA 510(k) clearance K081868 · decided 2011-05-25
Clearance details
- K-number
- K081868
- Device name
- SMART LEISH, MODEL LGM1-050
- Applicant
- U.S. Army Medical Research Institute of Infectious
- Decision
- Substantially Equivalent
- Date received
- 2008-07-02
- Decision date
- 2011-05-25
- Days to decision
- 1057 days
- Clearance type
- Traditional
- Product code
- OUZ
- Device class
- 1
- Regulation number
- 866.3870
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Fort Detrick, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.