510(k) K941872 ยท GGC Control, Plasma, Abnormal
SPECIALTY ASSAYED CONTROL-2 CAT. NO. 5302
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Nov 21, 1994 |
| Received | Apr 18, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K941872
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.