NBS — Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1) Class II
FDA product code NBS covers "Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1)", a Class II medical device regulated under 21 CFR 866.5660. Submissions are reviewed by the Immunology panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NBS
- Device Class
- Class II
- Regulation Number
- 866.5660
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K163538 | inova diagnostics | QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM | September 6, 2017 |
| K112223 | euroimmun us | EUROIMMUN ANTI-LKM-1 ELISA(LGG) | September 11, 2012 |
| K000535 | inova diagnostics | QUANTA LITE LKM-1 ELISA | June 7, 2000 |