510(k) K100103 ยท GGC Control, Plasma, Abnormal
SPECIALTY ASSAYED CONTROL-2
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Dec 15, 2010 |
| Received | Jan 13, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100103
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.