510(k) K110605 ยท NQM Immunoassay For Detection Of Amniotic Fluid Protein(S).
ROM PLUS
| Applicant | Clinical Innovations, LLC, Murray UT, US |
| Decision | Substantially Equivalent, Nov 23, 2011 |
| Received | Mar 2, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110605
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 13, 2020 | Clinical Innovations, LLC Clinical Innovations ROM Plus Collection Kit
IFU:
ROM Plus Rupture of Membrane Test ROM-5025, ROM-6025 Terminated |
NQM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.