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
1388206309
Device Listing 1388206309
Listing Summary
#
Listing key
1388206309
Premarket submission
K122907
Device
FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTER
Applicant
Polymed Therapeutics, Inc.
Product code
LCX
Decision date
2013-03-14
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
222654
3014862351
3014862351
AZURE BIOTECH INC
1
Y
2026-01-01
10400 Main Street Houston TX US 77025