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FDA Product Code

FDA Product Code NBO — Clearance Directory

Device Class
Class II
Assigned Panel
Immunology
21 CFR Citation
866.5660

510(k) Clearances — 2 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K091969 EUROIMMUN ANTI-DESMOGLEIN 1 ELISA (IGG), EUROIMMUN ANTI-DESMOGLEIN 3 ELISA (IGG) Euroimmun Us, Inc. 2010-09-02 Traditional PDF ↗
K000336 RHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, MODEL 7680 E Rhigene, Inc. 2000-06-09 Traditional PDF ↗

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