510(k) K973040 ยท CFF Immunoelectrophoretic, Immunoglobulins, (G, A, M)
SPIFE IFE-6
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Jan 2, 1998 |
| Received | Aug 14, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973040
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 21, 2017 | Helena Laboratories, Corp. SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX. Terminated |
CFF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.