510(k) K781578 ยท JHI Visual, Pregnancy Hcg, Prescription Use
RIA QUANT B-HCG TEST KIT
| Applicant | Mallinckrodt Critical Care, Mchenry IL, US |
| Decision | Substantially Equivalent, Oct 10, 1978 |
| Received | Sep 15, 1978 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K781578
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.