Device Classification Name |
assay, nucleic acid amplification, bacillus anthracis
|
510(k) Number |
K192871 |
Device Name |
B. anthracis Real-time PCR Assay |
Applicant |
Centers for Disease Control and Prevention |
1600 Clifton Road NE, MS: H24-11 |
Atlanta,
GA
30329
|
|
Applicant Contact |
Yon Yu |
Correspondent |
Centers for Disease Control and Prevention |
1600 Clifton Road NE, MS: H24-11 |
Atlanta,
GA
30329
|
|
Correspondent Contact |
Julie Villanueva |
Regulation Number | 866.3045
|
Classification Product Code |
|
Date Received | 10/08/2019 |
Decision Date | 11/07/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|