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
1212912019
Device Listing 1212912019
Listing Summary
#
Listing key
1212912019
Premarket submission
K182389
Device
Sysmex XN-L Automated Hematology Analyzer
Applicant
Sysmex America, Inc.
Product code
GKZ
Decision date
2019-01-25
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
15590
9613959
3002808301
Simon C. Shorter
1
N
2027-01-01
577 APTAKISIC RD Lincolnshire IL US 60069
104480
3002759288
3002759288
SYSMEX CORPORATION KAKOGAWA FACTORY
1
N
2027-01-01
314-2 Kitano, Noguchi-cho Kakogawa Hyogo JP 675-0011
143607
3009711478
3009711478
Sysmex America, Inc.
1
Y
2027-01-01
577 Aptakisic Rd Lincolnshire IL US 60069