510(k) K954732 ยท JHI Visual, Pregnancy Hcg, Prescription Use
ACCESS TOTAL BHCG ASSAY (MODIFICATION)
| Applicant | Bio-Rad Laboratories, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Nov 20, 1995 |
| Received | Oct 2, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954732
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.