510(k) K850531 ยท JHI Visual, Pregnancy Hcg, Prescription Use
LEECO CONCEP-7-BHCG EIA
| Applicant | Leeco Diagnostics, Inc., Southfield MI, US |
| Decision | Substantially Equivalent, Apr 2, 1985 |
| Received | Feb 11, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K850531
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.