Device Classification Name |
C. Difficile Toxin Gene Amplification Assay
|
510(k) Number |
K171441 |
Device Name |
ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit |
Applicant |
Luminex Corporation |
12212 Technology Blvd. |
Austin,
TX
78727
|
|
Applicant Contact |
Wendy Ricker |
Correspondent |
Luminex Corporation |
12212 Technology Blvd. |
Austin,
TX
78727
|
|
Correspondent Contact |
Wendy Ricker |
Regulation Number | 866.3130
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/16/2017 |
Decision Date | 07/21/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Clinical Trials |
NCT02497417
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|