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
1344644650
Device Listing 1344644650
Listing Summary
#
Listing key
1344644650
Premarket submission
K192719
Device
Osom Ultra Plus Flu A&B Test Kit
Applicant
SEKISUI Diagnostics, LLC
Product code
PSZ
Decision date
2020-04-03
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
126385
2030538
1000520007
Sekisui Diagnostics, LLC
1
Y
2026-01-01
6659 Top Gun St SAN DIEGO CA US 92121
284618
3017772438
3017772438
Sekisui Diagnostics, LLC
1
N
2026-01-01
6740 Cobra Way San Diego CA US 92121