510(k) K834270 ยท LCX Kit, Test, Pregnancy, Hcg, Over The Counter
ORTHO ENZYME IMMUNOASSAY HOME PREG.TEST
| Applicant | Advanced Care Products, Walker MI, US |
| Decision | Substantially Equivalent, May 14, 1984 |
| Received | Dec 8, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K834270
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.