510(k) K842633 ยท JHI Visual, Pregnancy Hcg, Prescription Use
TANDEM FAST VISUAL HCG ASSAY KIT -
| Applicant | Hybritech, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Aug 23, 1984 |
| Received | Jul 9, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K842633
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.