510(k) K870946 ยท LJP Antiserum, Fluorescent, Chlamydia Trachomatis
MONABRITE CHLAMYDIA TRACHOMATIS DIR. SPECIMEN TEST
| Applicant | Serono Diagnostics, Inc., Norwell MA, US |
| Decision | Substantially Equivalent, Apr 29, 1987 |
| Received | Mar 9, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K870946
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.