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FDA Product Code

FDA Product Code SIA — Clearance Directory

Device Class
Class II
Assigned Panel
Microbiology
21 CFR Citation
866.3984

510(k) Clearances — 1 record

K-Number Device Name Applicant Decision Date Clearance Type Summary
K253971 Visby Medical Flu and COVID-19 Test Visby Medical, Inc. 2026-05-27 Traditional PDF ↗

Product code SIA · Class II · Microbiology. Data: openFDA.