510(k) K030849 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
AMNISURE FETAL MEMBRANES RUPTURE TEST MODEL FMRT1
| Applicant | N-Dia, Inc., New York NY, US |
| Decision | Substantially Equivalent, Feb 2, 2004 |
| Received | Mar 17, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030849
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 19, 2008 | AmniSure International LLC AmniSure ROM Test, Fetal Membrane Rupture Test for
In-Vitro Diagnostic Use, Model: FMRT-1, AmniSure International LLC, Cambridge, MA 02138 Terminated |
JJX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.