510(k) K941737 ยท GIZ Plasma, Control, Normal
SPECIALTY ASSAYED CONTROL-1
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Oct 7, 1994 |
| Received | Apr 7, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K941737
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.