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FDA 510(k) Applications Submitted by PerkinElmer Inc.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K190266
02/08/2019
NeoLSD MSMS Kit
PerkinElmer Inc.
K190335
02/14/2019
GSP Neonatal Total Galactose kit
PerkinElmer Inc.
DEN180056
10/11/2018
GSP Neonatal Creatine Kinase - MM kit
PerkinElmer Inc.
DEN200044
07/08/2020
Eonis SCID-SMA Kit
PerkinElmer Inc.
K193103
11/08/2019
NeoBase 2 Non-derivatized MSMS Kit
PerkinElmer Inc.
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