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.
Clearance details
- Applicant
- Amnisure International, LLC
- Product code
- Code NQM
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cambridge, MA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.