Panels › Immunology › Product code OBZ · Class 2
Alpha-1-Antitrypsin Kit, Qualitative Phenotype
Regulation 866.5130
0510(k)s in 12 months (2 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in OBZ
| Company | 510(k)s | Recalls |
|---|---|---|
| Helena Laboratories, Corp. | 1 | 0 |
| Sebia | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 13, 2022 | K213396 | SPIFE A1AT kit Helena Laboratories, Corp. | OBZ |
| Jun 11, 2007 | K063498 | HYDRAGEL 18 A1AT ISOFOCUSING KIT (PN 4356) Sebia | OBZ |
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