510(k) K850727 ยท JHI Visual, Pregnancy Hcg, Prescription Use
BHCG-ROCHE EIA
| Applicant | Hoffmann-La Roche, Inc., Nutley NJ, US |
| Decision | Substantially Equivalent, Jun 25, 1985 |
| Received | Feb 22, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K850727
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.