510(k) K192931 ยท GKA Abnormal Hemoglobin Quantitation
V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control
| Applicant | Helena Laboratories, Corp., Beaumont TX, US |
| Decision | Substantially Equivalent, Apr 19, 2022 |
| Received | Oct 17, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192931
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.