The following data is part of a premarket notification filed by U.s. Army Medical Research Institute Of Infectious with the FDA for Smart Leish, Model Lgm1-050.
| Device ID | K081868 |
| 510k Number | K081868 |
| Device Name: | SMART LEISH, MODEL LGM1-050 |
| Classification | Nucleic Amplification Assays For The Detection Of Leishmania Nucleic Acids |
| Applicant | U.S. ARMY MEDICAL RESEARCH INSTITUTE OF INFECTIOUS 1452 PORTER STREET Fort Detrick, MD 21702 -9232 |
| Contact | Rober Miller |
| Correspondent | Rober Miller U.S. ARMY MEDICAL RESEARCH INSTITUTE OF INFECTIOUS 1452 PORTER STREET Fort Detrick, MD 21702 -9232 |
| Product Code | OUZ |
| CFR Regulation Number | 866.3870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-02 |
| Decision Date | 2011-05-25 |
| Summary: | summary |