510(k) K833137 ยท JHJ Agglutination Method, Human Chorionic Gonadotropin
ORTHO B-HCG SLIDE TEST FOR PREGNANCY
| Applicant | Ortho Diagnostic Systems, Inc., Carpinteria CA, US |
| Decision | Substantially Equivalent, Jan 18, 1984 |
| Received | Sep 14, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K833137
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.