THE BINDING SITE, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20835662083566THE BINDING SITE, INC.1Y2026-01-019606 Kearny Villa Rd SAN DIEGO CA US 92126

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
352931259046408K250549Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free KitDFH2025-05-23
352932012048211K173732Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free KitDFH2018-08-23
352931925379135K150658Optilite FreeLite Kappa Free Kit, Optilite Freelite Lambda Free KitDFH2015-08-26
352931004520135K070900FREELITE HUMAN KAPPA AND LAMBDA FREE DIAGNOSTIC TEST KITS FOR USE ON THE ROCHE COBAS INTEGRA 400/400 PLUS ANALYZER KITDFH2007-11-30

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DFH42025-05-23