NBS — Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1) Class II
FDA Device Classification
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 |