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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzymatic Methods, Galactose
510(k) Number K071649
Device Name NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110B
Applicant
Wallac OY
940 Winter St.
Waltham,  MA  02451
Applicant Contact CINDY LLOYD
Correspondent
Wallac OY
940 Winter St.
Waltham,  MA  02451
Correspondent Contact CINDY LLOYD
Regulation Number862.1310
Classification Product Code
JIA  
Date Received06/18/2007
Decision Date 08/07/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
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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