510(k) K863841 ยท LCX Kit, Test, Pregnancy, Hcg, Over The Counter
TANDEM OTC HCG PREGNANCY TEST FOR CONSUMER USE
| Applicant | Hybritech, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Dec 22, 1986 |
| Received | Oct 1, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K863841
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.