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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Immunoassay For Detection Of Amniotic Fluid Protein(S).
510(k) Number K081767
Device Name AMNISURE FETAL MEMBRANES RUPTURE TEST, MODEL FMRT-1
Applicant
Amnisure International, LLC
30 Jfk St. , 4th Floor
Cambridge,  MA  02138
Applicant Contact MICHAEL FRIEDMAN
Correspondent
Amnisure International, LLC
30 Jfk St. , 4th Floor
Cambridge,  MA  02138
Correspondent Contact MICHAEL FRIEDMAN
Regulation Number862.1550
Classification Product Code
NQM  
Date Received06/20/2008
Decision Date 01/09/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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