510(k) K013907 ยท LCX Kit, Test, Pregnancy, Hcg, Over The Counter
INVERNESS MEDICAL EARLY PREGNANCY TEST
| Applicant | Cambridge Diagnostics Ireland, Ltd., Galway, IE |
| Decision | Substantially Equivalent, Dec 18, 2001 |
| Received | Nov 26, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K013907
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.