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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 K162451
Device Name Solana HSV 1+2/VZV Assay
Applicant
QUIDEL CORPORATION
2005 EAST STATE STREET, SUITE 100
ATHENS,  OH  45701
Applicant Contact Ronald H. Lollar
Correspondent
QUIDEL CORPORATION
2005 EAST STATE STREET, SUITE 100
ATHENS,  OH  45701
Correspondent Contact Ronald H. Lollar
Regulation Number866.3309
Classification Product Code
PGI  
Date Received09/01/2016
Decision Date 11/28/2016
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
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