510(k) K853738 ยท LJP Antiserum, Fluorescent, Chlamydia Trachomatis
ORTHO CHLAMYDIA DIRECT DETECTION (FA) TEST
| Applicant | Ortho Diagnostic Systems, Inc., Carpinteria CA, US |
| Decision | Substantially Equivalent, Dec 6, 1985 |
| Received | Sep 6, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K853738
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.