510(k) K850079 ยท LCX Kit, Test, Pregnancy, Hcg, Over The Counter
NOW HOME PREGN. TEST KIT ENZYME IMMUNOASSAY HCG
| Applicant | Bioclinical Systems, Inc., St.Louis MO, US |
| Decision | Substantially Equivalent, Mar 5, 1985 |
| Received | Jan 10, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K850079
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.