510(k) K873033 ยท JHI Visual, Pregnancy Hcg, Prescription Use
HCG SEROZYME IMMUNOENZYM ASSAY KIT/MAG SOLID PHASE
| Applicant | Serono Diagnostics, Inc., Norwell MA, US |
| Decision | Substantially Equivalent, Sep 14, 1987 |
| Received | Aug 4, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K873033
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.