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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cytomegalovirus (Cmv) Dna Quantitative Assay
510(k) Number K243935
Device Name Aptima CMV Quant Assay
Applicant
Hologic, Inc.
10210 Genetic Center Dr.
San Diedgo,  CA  92121
Applicant Contact Maria Jose Cortes-Mateos
Correspondent
Hologic, Inc.
10210 Genetic Center Dr.
San Diedgo,  CA  92121
Correspondent Contact Maria Jose Cortes-Mateos
Regulation Number866.3180
Classification Product Code
PAB  
Date Received12/20/2024
Decision Date 01/17/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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