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
1247474636
Device Listing 1247474636
Listing Summary
#
Listing key
1247474636
Premarket submission
K254059
Device
Access anti-HBc IgM
Applicant
Beckman Coulter, Inc.
Product code
SEI
Decision date
2026-03-13
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
5261
8023018
3002807272
Ian Pilcher
1
N
2026-01-01
1000 Lake Hazeltine Dr Chaska MN US 55318
107181
9680746
1000206808
Ian Pilcher
1
N
2026-01-01
1000 Lake Hazeltine Dr Chaska MN US 55318