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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single (Specified) Analyte Controls (Assayed And Unassayed)
510(k) Number K030849
Device Name AMNISURE FETAL MEMBRANES RUPTURE TEST MODEL FMRT1
Applicant
N-DIA, INC.
30 E. 20TH ST., STE. 501
NEW YORK,  NY  10003
Applicant Contact MICHAEL FRIEDMAN
Correspondent
N-DIA, INC.
30 E. 20TH ST., STE. 501
NEW YORK,  NY  10003
Correspondent Contact MICHAEL FRIEDMAN
Regulation Number862.1660
Classification Product Code
JJX  
Subsequent Product Code
NQM  
Date Received03/17/2003
Decision Date 02/02/2004
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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