FDA.reportPublic FDA data

BIOINTELLISENSE INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30165926823016592682BIOINTELLISENSE INC.1N2026-01-01805 Veterans Blvd UNIT 105 Redwood City CA US 94063
30179860703017986070BIOINTELLISENSE INC.1Y2026-01-01611 Corporate Cir Ste E-H Golden CO US 80401

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2390981081112677K241101BioButton SystemDRG2024-09-26
3062651081112677K241101BioButton SystemDRG2024-09-26
3062651717072602K212957BioButton SystemDRG2022-12-12
2390981717072602K212957BioButton SystemDRG2022-12-12
2390981289220509K191614BioSticker SystemDRG2019-12-18
3062651289220509K191614BioSticker SystemDRG2019-12-18
2390981414831568
3062651414831568
2390981806717086

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DRG62024-09-26

PMN#