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 Number | 866.3309
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/13/2015 |
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
|
Recalls |
CDRH Recalls
|
|
|