510(k) K043385 ยท JHI Visual, Pregnancy Hcg, Prescription Use
OSOM HCG COMBO TEST
| Applicant | Genzyme Diagnostics, San Diego CA, US |
| Decision | Substantially Equivalent, Apr 12, 2005 |
| Received | Dec 9, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043385
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.