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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 K133652
Device Name GSP NEONATAL TOTAL GALACTOSE KIT
Applicant
Wallac Oy, A Subsidiary of Perkinelmer, Inc.
940 Winter St.
Waltham,  MA  02451
Applicant Contact JEANETTE SCHIER-PUGSLEY
Correspondent
Wallac Oy, A Subsidiary of Perkinelmer, Inc.
940 Winter St.
Waltham,  MA  02451
Correspondent Contact JEANETTE SCHIER-PUGSLEY
Regulation Number862.1310
Classification Product Code
JIA  
Date Received11/27/2013
Decision Date 04/28/2014
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
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