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
1797097288
Device Listing 1797097288
Listing Summary
#
Listing key
1797097288
Premarket submission
K963847
Device
WAKO DIRECT HDL-C
Applicant
Wako Chemicals USA, Inc.
Product code
JIS
Decision date
1996-12-24
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
232819
3005625991
3005625991
FUJIFILM Healthcare Americas Corporation
1
N
2026-01-01
1100 King Georges Post Rd Edison NJ US 08837