510(k) K881125 ยท LIO Device, Specimen Collection
PATHFINDER(TM) CHLAMYDIA EIA BRUSH COLLECTION KIT
| Applicant | Kallestad Diag, A Div. of Erbamont, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Mar 23, 1988 |
| Received | Mar 16, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K881125
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.