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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples
510(k) Number K232286
Device Name Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument
Applicant
Quidel Corporation
10165 Mckellar Ct.
San Diego,  CA  92121
Applicant Contact Ronald Lollar
Correspondent
Quidelortho Corporation
9975 Summers Ridge Rd.
San Diego,  CA  92121
Correspondent Contact Selena Liu
Regulation Number866.3309
Classification Product Code
PGI  
Subsequent Product Codes
OOI   PMN  
Date Received08/01/2023
Decision Date 12/20/2023
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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