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FDA Product Code

FDA Product Code OEG — Clearance Directory

Device Class
Class II
Assigned Panel
Immunology
21 CFR Citation
866.5660

510(k) Clearances — 3 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K193115 EUROIMMUN Anti-BP230-CF ELISA (IgG) Euroimmun Us, Inc. 2020-09-17 Traditional PDF ↗
K083615 EUROIMMUN ANTI BP 180-4X ELISA (IGG) Euroimmun Us, Inc. 2009-03-16 Traditional PDF ↗
K071961 MESACUP MODELS BP180 AND BP230 ELISA KITS Mbl International Corporation 2008-08-25 Traditional PDF ↗

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