The following data is part of a premarket notification filed by Amnisure International, Llc with the FDA for Amnisure Fetal Membranes Rupture Test, Model Fmrt-1.
| Device ID | K081767 |
| 510k Number | K081767 |
| Device Name: | AMNISURE FETAL MEMBRANES RUPTURE TEST, MODEL FMRT-1 |
| Classification | Immunoassay For Detection Of Amniotic Fluid Protein(s). |
| Applicant | AMNISURE INTERNATIONAL, LLC 30 JFK STREET , 4TH FLOOR Cambridge, MA 02138 |
| Contact | Michael Friedman |
| Correspondent | Michael Friedman AMNISURE INTERNATIONAL, LLC 30 JFK STREET , 4TH FLOOR Cambridge, MA 02138 |
| Product Code | NQM |
| CFR Regulation Number | 862.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-20 |
| Decision Date | 2009-01-09 |