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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, Toxoplasma Gondii
510(k) Number K210596
Device Name ARCHITECT Toxo IgG
Applicant
Abbott Laboratories
Dept 09aa, Bldg. Ap8-1, 100 Abbott Park Rd.
Abbott Park,  IL  60064
Applicant Contact Linda Sohn
Correspondent
Abbott Laboratories
Dept 09aa, Bldg. Ap8-1, 100 Abbott Park Rd.
Abbott Park,  IL  60064
Correspondent Contact Linda Sohn
Regulation Number866.3780
Classification Product Code
LGD  
Subsequent Product Code
QCH  
Date Received03/01/2021
Decision Date 05/19/2022
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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