FDA.reportPublic FDA data

ELUTE, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30219884993021988499ELUTE, INC.1N2026-01-01417 S WAKARA WAY, #3510 Salt Lake City UT US 84108

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3059551971503864K250346BonVie+MQV2025-02-26
3059551347439949K180853EP Granules™ BVFMQV2018-08-06

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MQV22025-02-26

PMN#