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
1117337778
Device Listing 1117337778
Listing Summary
#
Listing key
1117337778
Premarket submission
K152556
Device
Oragene Dx
Applicant
DNA Genotek, Inc.
Product code
OYJ
Decision date
2016-05-26
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
309886
3011845225
3011845225
COLOR DIAGNOSTICS, LLC
1
N
2026-01-01
365 Oyster Point Blvd Suite 300-3A South San Francisco CA US 94080