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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 K151906
Device Name ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD), ARIES HSV 1&2 Assay Cassette (IVD)
Applicant
LUMINEX CORPORATION
12212 TECHNOLOGY BLVD.
austin,  TX  78727
Applicant Contact ronald dunn
Correspondent
LUMINEX CORPORATION
12212 TECHNOLOGY BLVD.
austin,  TX  78727
Correspondent Contact ronald dunn
Regulation Number866.3309
Classification Product Code
PGI  
Subsequent Product Code
OOI  
Date Received07/13/2015
Decision Date 10/06/2015
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
summary summary
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT02092233
Reviewed by Third Party No
Combination Product No
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