510(k) K913384 ยท JPD Hemoglobin A2 Quantitation
COLUMNMATE(TM) BETA-THAL CAT. NO. 4515
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Dec 17, 1991 |
| Received | Jul 29, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913384
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.