510(k) K911826 ยท JHI Visual, Pregnancy Hcg, Prescription Use
IMMUNOCARD HCG ONE STEP (I-S) TEST KIT
| Applicant | Disease Detection International, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Jul 19, 1991 |
| Received | Apr 24, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911826
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.