510(k) K003856 ยท JHI Visual, Pregnancy Hcg, Prescription Use
EZ-HCG URINE(PREGNANCY TEST)
| Applicant | Biomerica, Inc., Newport Beach CA, US |
| Decision | Substantially Equivalent, Feb 21, 2001 |
| Received | Dec 13, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003856
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.