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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
510(k) Number K220949
Device Name Architect CMV IgG
Applicant
Abbott Laboratories
Dept 09aa, Bldg. Ap8a, 100 Abbott Park Rd.
Abbott Park,  IL  60064
Applicant Contact Shannon Reibling
Correspondent
Abbott Laboratories
Dept 09aa, Bldg. Ap8a, 100 Abbott Park Rd.
Abbott Park,  IL  60064
Correspondent Contact Shannon Reibling
Regulation Number866.3175
Classification Product Code
LFZ  
Date Received04/01/2022
Decision Date 10/27/2022
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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