510(k) K081767 ยท NQM Immunoassay For Detection Of Amniotic Fluid Protein(S).
AMNISURE FETAL MEMBRANES RUPTURE TEST, MODEL FMRT-1
| Applicant | Amnisure International, LLC, Cambridge MA, US |
| Decision | Substantially Equivalent, Jan 9, 2009 |
| Received | Jun 20, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081767
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 21, 2020 | Qiagen Sciences LLC AmniSure ROM Test, Material Nos. FMRT-1-25-US (US Distribution, 25 tests/box), FMRT-1-10-US (US Distribution, 10 tests/box), FMRT-1-25-CA (Canadian Distribution; 25 tests/box) Terminated |
NQM | None listed |
| Jul 13, 2018 | Qiagen Sciences, Inc. AmniSure ROM Test under the following labels: 1) Catalog Number FMRT-1-25 and 2) Catalog Number FMRT-1-25-CA
Product Usage:
Rapid, non-instrumented, qualitative immunochromatographic test for the in Terminated |
NQM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.