510(k) K871235 ยท JHI Visual, Pregnancy Hcg, Prescription Use
TANDEM(R) ICON(R) QSR(TM) HCG IMMUNO. ASSAY KIT
| Applicant | Hybritech, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Jun 3, 1987 |
| Received | Mar 27, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K871235
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.