510(k) K894420 ยท JHI Visual, Pregnancy Hcg, Prescription Use
ORTHO RESULT PLUS/PREGNANCY
| Applicant | Ortho Diagnostic Systems, Inc., Raritan NJ, US |
| Decision | Substantially Equivalent, Oct 4, 1989 |
| Received | Jul 17, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K894420
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.