510(k) K881500 ยท LJP Antiserum, Fluorescent, Chlamydia Trachomatis
ORTHO* CHLAMYDIA DIRECT DETECTION (FA) TEST
| Applicant | Ortho Diagnostic Systems, Inc., Carpinteria CA, US |
| Decision | Substantially Equivalent, Apr 27, 1988 |
| Received | Apr 11, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K881500
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.