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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 K180559
Device Name HSV 1 & 2 ELITe MGB Kit; ELITe InGenius
Applicant
ELITechGroup
21720 23rd Drive SE Suite 150
bothell,  WA  98021
Applicant Contact terry trimingham
Correspondent
ELITechGroup
21720 23rd Drive SE Suite 150
bothell,  WA  98021
Correspondent Contact walt mahoney
Regulation Number866.3309
Classification Product Code
PGI  
Subsequent Product Code
OOI  
Date Received03/01/2018
Decision Date 10/29/2018
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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