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
1803774242
Device Listing 1803774242
Listing Summary
#
Listing key
1803774242
Premarket submission
K250965
Device
Automated Blood Coagulation Analyzer CN-Series (CN-6000)
Applicant
Sysmex America, Inc.
Product code
JPA
Decision date
2025-06-02
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
15590
9613959
3002808301
SYSMEX CORPORATION TECHNO PARK
1
N
2026-01-01
4-4-4 TAKATSUKADAI NISHI-KU KOBE Hyogo JP 651-2271
143607
3009711478
3009711478
Sysmex America, Inc.
1
Y
2026-01-01
577 Aptakisic Rd Lincolnshire IL US 60069
165233
3010421384
3010421384
Simon C. Shorter
1
N
2026-01-01
577 APTAKISIC RD Lincolnshire IL US 60069
172997
3010960914
3010960914
SYSMEX CORPORATION i-SQUARE
1
N
2026-01-01
262-11 Mizuashi, Noguchicho Kakogawa Hyogo JP 675-0019