Device Classification Name |
Real Time Nucleic Acid Amplification System
|
510(k) Number |
K161495 |
Device Name |
ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD) |
Applicant |
LUMINEX CORPORATION |
12212 TECHNOLOGY BLVD. |
AUSTIN,
TX
78727
|
|
Applicant Contact |
CHRISTIE HUGHES |
Correspondent |
LUMINEX CORPORATION |
12212 TECHNOLOGY BLVD. |
AUSTIN,
TX
78727
|
|
Correspondent Contact |
CHRISTIE HUGHES |
Regulation Number | 862.2570
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/01/2016 |
Decision Date | 06/30/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Microbiology
|
Statement |
Statement
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|