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)

Herpes Virus (vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples

LUMINEX CORPORATION

The following data is part of a premarket notification filed by Luminex Corporation with the FDA for 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).

Pre-market Notification Details

Device IDK151906
510k NumberK151906
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)
ClassificationHerpes Virus (vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples
Applicant LUMINEX CORPORATION 12212 TECHNOLOGY BLVD. Austin,  TX  78727
ContactRonald Dunn
CorrespondentRonald Dunn
LUMINEX CORPORATION 12212 TECHNOLOGY BLVD. Austin,  TX  78727
Product CodePGI  
CFR Regulation Number866.3309 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-07-13
Decision Date2015-10-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840487101537 K151906 000
00840487100295 K151906 000

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