510(k) K031798 ยท LCX Kit, Test, Pregnancy, Hcg, Over The Counter
GOOD MORNING TEST
| Applicant | Standard Diagnostics, Inc., Sound Beach NY, US |
| Decision | Substantially Equivalent, Nov 12, 2003 |
| Received | Jun 10, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031798
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.