FDA.reportPublic FDA data

OTC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30134256563013425656OTC DENTAL1N2026-01-013825 W Cheyenne Ave Ste 606 N Las Vegas NV US 89032
30121407263012140726OTC OUTLET INC.1Y2020-04-2517 Jackson St Freehold NJ US 07728

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2031711855771814K974865CSREBI1998-03-16
1899141708442522K170079Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood Glucose Monitoring SystemNBW2017-10-06
2031711543411983

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NBW12017-10-06
EBI11998-03-16

NDC#

PMN#