Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

The Binding Site

FDA 510(k) & PMA Approved Devices — 9 products

Total Devices9
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K132555 HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KITPCN2013-12-20 View
510(k) K103824 HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUSCFN2012-02-27 View
510(k) K100455 SPAPLUS ANALYZERDBI2010-09-03 View
510(k) K092450 HUMAN IGD KIT FOR USE ON SPAPLUSCZJ2009-12-28 View
510(k) K072166 CYSTATIN C KIT FOR USE ON THE SPAPLUS ANALYZERNDY2008-01-24 View
510(k) K042579 BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KITNBT2005-07-28 View
510(k) K042152 BINDING SITE IGG SUBLCASS OLYMPUS KITSCFN2004-11-22 View
510(k) K041891 MININEPH HUMAN RHEUMATOID FACTOR KITDHR2004-11-05 View
510(k) K040466 BINDAZYME HUMAN ANTI TISSUE TRANSGLUTAMINASE IGA AND IGG EIA DIAGNOSTIC TEST KITSMVM2004-07-16 View
↑