FDA Product Code
FDA Product Code NBS — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5660
510(k) Clearances — 3 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K163538 | QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls | Inova Diagnostics, Inc. | 2017-09-06 | Traditional | PDF ↗ |
| K112223 | EUROIMMUN ANTI-LKM-1 ELISA(LGG) | Euroimmun US | 2012-09-11 | Traditional | PDF ↗ |
| K000535 | QUANTA LITE LKM-1 ELISA | Inova Diagnostics, Inc. | 2000-06-07 | Traditional | PDF ↗ |
Product code NBS · Class II · Immunology. Data: openFDA.