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
1086769905
Device Listing 1086769905
Listing Summary
#
Listing key
1086769905
Premarket submission
K182298
Device
hemochroma PLUS System
Applicant
Immunostics Inc.,
Product code
GKR
Decision date
2018-11-16
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
171344
3009491259
3009491259
BODITECH MED INC.
1
N
2026-01-01
43, Geodudanji 1-gil, Dongnae-myeon Chuncheon Gangwon KR 24398