FDA Product Code
FDA Product Code SEI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Microbiology
- 21 CFR Citation
- 866.3173
510(k) Clearances — 4 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260049 | Elecsys Anti-HBc IgM | Roche Diagnostics | 2026-04-07 | Traditional | PDF ↗ |
| K260046 | Elecsys Anti-HBc II | Roche Diagnostics | 2026-04-07 | Traditional | PDF ↗ |
| K254059 | Access anti-HBc IgM | Beckman Coulter, Inc. | 2026-03-13 | Traditional | PDF ↗ |
| K253687 | Access anti-HBc Total | Beckman Coulter, Inc. | 2026-02-19 | Traditional | PDF ↗ |
Product code SEI · Class II · Microbiology. Data: openFDA.