510(k) K213396 ยท OBZ Alpha-1-Antitrypsin Kit, Qualitative Phenotype
SPIFE A1AT kit
| Applicant | Helena Laboratories, Corp., Beaumont TX, US |
| Decision | Substantially Equivalent, Oct 13, 2022 |
| Received | Oct 18, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213396
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.