FDA Product Code
FDA Product Code OBZ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5130
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K213396 | SPIFE A1AT kit | Helena Laboratories, Corp. | 2022-10-13 | Traditional | PDF ↗ |
| K063498 | HYDRAGEL 18 A1AT ISOFOCUSING KIT (PN 4356) | Sebia | 2007-06-11 | Traditional | PDF ↗ |
Product code OBZ · Class II · Immunology. Data: openFDA.