FDA.reportPublic FDA data

HEALGEN LIFE SCIENCE LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30383713353038371335HEALGEN LIFE SCIENCE LLC1Y2026-01-013818 Fuqua St Houston TX US 77047

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3392611956609105K251972Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180)DJG2025-08-15
3392611267320770

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DJG12025-08-15