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FDA Product Code

FDA Product Code SBE — Clearance Directory

Device Class
Class II
Assigned Panel
General Hospital
21 CFR Citation
880.2801

510(k) Clearances — 1 record

K-Number Device Name Applicant Decision Date Clearance Type Summary
DEN230068 3M™ Attest™ eBowie-Dick Test Card 10135 3M™ Attest™ eBowie-Dick Card Holder 10135CH 3M™ Attest™ eBowie-Dick Auto-reader 1190 3M Company 2024-05-21 Direct —

Product code SBE · Class II · General Hospital. Data: openFDA.