510(k) K081767
K081767 is an FDA 510(k) premarket notification submitted by Amnisure International, LLC for the device "AMNISURE FETAL MEMBRANES RUPTURE TEST, MODEL FMRT-1". The FDA issued a decision of Substantially Equivalent on January 9, 2009. The device falls under product code NQM (Immunoassay For Detection Of Amniotic Fluid Protein(S).), a Class I device regulated under 21 CFR 862.1550.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 9, 2009
- Date Received
- June 20, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Immunoassay For Detection Of Amniotic Fluid Protein(S).
- Device Class
- Class I
- Regulation Number
- 862.1550
- Review Panel
- CH
- Submission Type
The test is for use by health care professionals to aid in the detection of fetal membrane rupture in pregnant women, when they report signs, symptoms or complaints suggestive of such rupture.