Skip to content
FDA.report
Public FDA data
NDC
RxNorm
DailyMed
Applications
GUDID
GMDN
PMA
PMN
MAUDE
Recalls
Search FDA.report
Search
Home
Company-Registration
1436192024
Device Listing 1436192024
Listing Summary
#
Listing key
1436192024
Premarket submission
K133652
Device
GSP NEONATAL TOTAL GALACTOSE KIT
Applicant
Wallac Oy, A Subsidiary of Perkinelmer, Inc.
Product code
JIA
Decision date
2014-04-28
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
26710
8043909
3002808498
Daniel Castellanos
1
N
2026-01-01
77 4th Avenue Waltham MA US 02451