PerkinElmer Health Sciences, Inc. - Aug. 1, 2019
Issue Date
Aug 01, 2019
Region
Northeast
Category
Device
$117.00
Contact Name
Felix N. Martinez
Contact Title
VP Global Quality, Regulatory, and Medical
Address 1
940 Winter St.
City
Waltham
State
MA
Zip/Postal Code
02451-1457
Country
United States
Inspection Range
Jul 09, 2019 - Aug 01, 2019
Pages
5
First Observation
Premarket Notification was not submitted to the FDA at least 90 days before the introduction into
interstate commerce for commercial distribution of a device intended for human use.
Investigator(s): Justine Corson