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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Campylobacter Spp.
510(k) Number K211342
Device Name Sofia 2 Campylobacter FIA
Applicant
Quidel Corporation
10165 Mckellar Ct.
San Diego,  CA  92121
Applicant Contact Michelle Bodien
Correspondent
Quidel Corporation
10165 Mckellar Ct.
San Diego,  CA  92121
Correspondent Contact Michelle Bodien
Regulation Number866.3110
Classification Product Code
LQP  
Subsequent Product Code
KHO  
Date Received05/03/2021
Decision Date 11/23/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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