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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
510(k) Number K233352
Device Name Aptima HCV Quant Dx Assay
Applicant
Hologic, Inc.
10210 Genetic Center Dr.
San Diedgo,  CA  92121
Applicant Contact Howard Liu
Correspondent
Hologic, Inc.
10210 Genetic Center Dr.
San Diedgo,  CA  92121
Correspondent Contact Howard Liu
Regulation Number866.3170
Classification Product Code
MZP  
Date Received09/29/2023
Decision Date 07/24/2024
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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