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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 K190335
Device Name GSP Neonatal Total Galactose kit
Applicant
PerkinElmer Inc.
940 Winter Street
Waltham,  MA  02451
Applicant Contact Brian Ciccariello
Correspondent
PerkinElmer Inc.
940 Winter Street
Waltham,  MA  02451
Correspondent Contact Brian Ciccariello
Regulation Number862.1310
Classification Product Code
JIA  
Date Received02/14/2019
Decision Date 11/06/2019
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
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