510(k) K880031 ยท LJP Antiserum, Fluorescent, Chlamydia Trachomatis
PATHFINDER(TM) DIRECT DETECTION SYS C. TRACHOMATIS
| Applicant | Kallestad Diag, A Div. of Erbamont, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Mar 17, 1988 |
| Received | Jan 5, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K880031
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.