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FDA Product Code

FDA Product Code NYO — Clearance Directory

Device Class
Class II
Assigned Panel
Immunology
21 CFR Citation
866.5100

510(k) Clearances — 4 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K202541 EliA RNA Pol III Phadia AB 2021-09-13 Traditional PDF ↗
K172078 ImmuLisa Enhanced RNA POL III Antibody ELISA Immco Diagnostics, Inc. 2018-03-30 Traditional PDF ↗
K070066 QUANTA LITE RNA POL III ELISA Inova Diagnostics, Inc. 2007-04-11 Traditional PDF ↗
K060431 ANTI RNA POLYMERASE III ELISA KIT, MODEL 7805 Mbl International Corporation 2006-06-19 Traditional PDF ↗

Product code NYO · Class II · Immunology. Data: openFDA.