510(k) K881709 ยท JHI Visual, Pregnancy Hcg, Prescription Use
IMMUNOCARD(TM) HCG II TEST KIT
| Applicant | Disease Detection International, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Jul 8, 1988 |
| Received | Apr 20, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K881709
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.