510(k) K982426 ยท JBD System, Analysis, Electrophoretic Hemoglobin
SPIFE ALKALINE HEMOGLOBIN
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Dec 17, 1998 |
| Received | Jul 13, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982426
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 27, 2018 | Helena Laboratories, Corp. SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415,
for use in the separation and quantitation of hemoglobins by agarose electrophoresis using the SPIFE systems Open, Classified |
JBD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.