AMNISURE FETAL MEMBRANES RUPTURE TEST, MODEL FMRT-1— 510(k) K081767
Substantially EquivalentAmnisure International, LLC
FDA 510(k) clearance K081767 for AMNISURE FETAL MEMBRANES RUPTURE TEST, MODEL FMRT-1, Substantially Equivalent on 2009-01-09. Applicant: Amnisure International, LLC. Device class: 1.
Clearance details
- Applicant
- Amnisure International, LLC
- Product code
- Code NQM
- Device class
- Class 1
- Regulation
- 21 CFR 862.1550
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cambridge, MA, US
Recent devices under product code NQM
view allRecalls naming K081767
K-number listed on FDA's recall record- Z-1636-2020 — 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)
- Z-2577-2018 — 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 vitro detection of amniotic fluid in vaginal discharge of pregnant women.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K081767.
Data sourced from openFDA. This site is unofficial and independent of the FDA.