510(k) K981391 ยท LIO Device, Specimen Collection
PAR-ONE
| Applicant | Remel, Inc., Lenexa KS, US |
| Decision | Substantially Equivalent, Jul 14, 1998 |
| Received | Apr 17, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981391
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.