510(k) K830138 ยท JHI Visual, Pregnancy Hcg, Prescription Use
TANDEM E GCG VISUAL END POINT INNUMOENZ
| Applicant | Hybritech, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Feb 7, 1983 |
| Received | Jan 13, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K830138
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.