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
1260093206
Device Listing 1260093206
Listing Summary
#
Listing key
1260093206
Premarket submission
K003359
Device
COLOSCREEN-ES
Applicant
Helena Laboratories
Product code
KHE
Decision date
2000-11-27
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
3118
1618982
1618982
HELENA LABORATORIES, CORP.
1
Y
2026-01-01
1530 Lindbergh Dr BEAUMONT TX US 77707