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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin
510(k) Number K102419
Device Name GSP NEONATAL IRT KIT (3306-001U)
Applicant
Wallac Oy, Subsidiary of Perkinelmer
940 Winter St.
Waltham,  MA  02451
Applicant Contact SUSAN K HAMANN
Correspondent
Wallac Oy, Subsidiary of Perkinelmer
940 Winter St.
Waltham,  MA  02451
Correspondent Contact SUSAN K HAMANN
Regulation Number862.1725
Classification Product Code
JNO  
Date Received08/25/2010
Decision Date 12/16/2010
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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