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
1133261303
Device Listing 1133261303
Listing Summary
#
Listing key
1133261303
Premarket submission
K052000
Device
ARCHITECT CA 19-9XR ASSAY
Applicant
Fujirebio Diagnostics,Inc.
Product code
NIG
Decision date
2005-10-25
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
115539
3002809144
3002809144
ABBOTT GmbH
1
N
2027-01-01
Max-Planck-Ring 2 Wiesbaden Hesse DE 65205
233388
3005333358
3005333358
ABBOTT LABORATORIES
1
N
2027-01-01
Conway Park 675 North Field Drive Lake Forest IL US 60045