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
1180455626
Device Listing 1180455626
Listing Summary
#
Listing key
1180455626
Premarket submission
K251543
Device
Atellica® IM TSH3-Ultra II (TSH3ULII)
Applicant
Siemens Healthcare Diagnostics, Inc.
Product code
JLW
Decision date
2026-02-06
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
67663
2432235
2432235
Siemens Healthcare Diagnostics Inc.
1
Y
2026-01-01
511 Benedict Ave Tarrytown NY US 10591
25697
3002637618
3002637618
Siemens Healthcare Diagnostics Inc
1
N
2026-01-01
Point Of Care Headquarters 333 Coney St East Walpole MA US 02032