510(k) K111369 ยท CFF Immunoelectrophoretic, Immunoglobulins, (G, A, M)
THE HELENA V8 IMMUNODISPLACEMENT KIT
| Applicant | Helena Laboratories Uk, Ltd., Beaumont TX, US |
| Decision | Substantially Equivalent, Jun 26, 2012 |
| Received | May 16, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111369
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 6, 2022 | Helena Laboratories, Corp. V8 Immunodisplacement Kit REF 1803 Open, Classified |
CFF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.