510(k) K010617 ยท DEW Igg, Antigen, Antiserum, Control
SPIFE IFE CALIBRATOR AND CONTROL KIT
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Mar 15, 2001 |
| Received | Mar 1, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010617
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.