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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name severe combined immunodeficiency disorder (scid) newborn screening test system
510(k) Number K203035
Device Name Eonis SCID-SMA kit
PerkinElmer Inc
940 Winter St
Waltham,  MA  02451
Applicant Contact Eva Nalian
PerkinElmer Inc
940 Winter St
Waltham,  MA  02451
Correspondent Contact Casey Fox
Regulation Number866.5930
Classification Product Code
Date Received10/05/2020
Decision Date 11/09/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Molecular Genetics
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No