Device Classification Name |
rickettsia spp. nucleic acid based detection assay
|
510(k) Number |
K170940 |
Device Name |
Rickettsia Real-time PCR Assay |
Applicant |
Centers for Disease Control and Prevention (CDC) |
1600 Clifton Road |
MS-C18 |
Atlanta,
GA
30329
|
|
Applicant Contact |
Yon Yu |
Correspondent |
Centers for Disease Control and Prevention (CDC) |
1600 Clifton Road |
MS-C18 |
Atlanta,
GA
30329
|
|
Correspondent Contact |
Yon Yu |
Regulation Number | 866.3316
|
Classification Product Code |
|
Date Received | 03/30/2017 |
Decision Date | 06/29/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|