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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Galectin-3 In Vitro Diagnostic Assay
510(k) Number K093758
Device Name BGM GALECTIN -3
Applicant
Bg Medicine, Inc.
610n Lincoln St.
Waltham,  MA  02451
Applicant Contact Carol Adiletto
Correspondent
Bg Medicine, Inc.
610n Lincoln St.
Waltham,  MA  02451
Correspondent Contact Carol Adiletto
Regulation Number862.1117
Classification Product Code
OSX  
Date Received12/07/2009
Decision Date 11/17/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT00738725
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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