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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alpha-D-Galactosidase A (Gla) Newborn Screening Test System
510(k) Number K190266
Device Name NeoLSD MSMS Kit
Applicant
Perkinelmer, Inc.
940 Winter St.
Waltham,  MA  02451
Applicant Contact Brian Ciccariello
Correspondent
Perkinelmer, Inc.
940 Winter St.
Waltham,  MA  02451
Correspondent Contact Brian Ciccariello
Classification Product Code
PQW  
Subsequent Product Codes
PQT   PQU   PQV   QCL   QCM  
Date Received02/08/2019
Decision Date 05/03/2019
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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