510(k) K081767
- Device
- AMNISURE FETAL MEMBRANES RUPTURE TEST, MODEL FMRT-1
- Applicant
- AMNISURE INTERNATIONAL, LLC
- 510(k) number
- K081767
- Product code
- NQM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-01-09
- Date received
- 2008-06-20
- Regulation
- 862.1550
- Classification name
- Immunoassay For Detection Of Amniotic Fluid Protein(s).
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- MICHAEL FRIEDMAN
- Address
- 30 Jfk St. , 4th Floor Cambridge MA US 02138 02138
FDA Registration Numbers#
- 1122376
- 1722684
- 1122236
- 1720929
- 2032098
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code NQM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K110605 | ROM PLUS | Clinical Innovations, LLC | 2011-11-23 |
Legacy Summary#
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FDA Review#
Decision Summary