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510(k) K190266

Device
NeoLSD MSMS Kit
Applicant
PerkinElmer Inc.
510(k) number
K190266
Product code
PQW  
Decision
Substantially Equivalent (SESE)
Decision date
2019-05-03
Date received
2019-02-08
Regulation
862.1488
Classification name
Alpha-d-galactosidase A (gla) Newborn Screening Test System
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Brian Ciccariello
Address
940 Winter St. Waltham MA US 02451 02451

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PQW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K173829NeoLSD MSMS kitWallac Oy, A Subsidiary of Perkinelmer2018-07-18
DEN150035SEEKER SystemBaebies, Inc.2017-02-03

Legacy Summary#

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FDA Review#

Decision Summary