510(k) K923318 ยท JPD Hemoglobin A2 Quantitation
COLUMNMATE BETA-THAL HBA2 CONTROL - NORMAL
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Aug 25, 1992 |
| Received | Jul 7, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K923318
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.