Device Classification Name |
Trichomonas Vaginalis Nucleic Acid Amplification Test System
|
510(k) Number |
K182692 |
Device Name |
BD MAX CTGCTV2, BD MAX System |
Applicant |
Becton, Dickinson and Company |
7 Loveton Circle |
Sparks,
MD
21152
|
|
Applicant Contact |
Katie Edwards |
Correspondent |
Becton, Dickinson and Company |
7 Loveton Circle |
Sparks,
MD
21152
|
|
Correspondent Contact |
Katie Edwards |
Regulation Number | 866.3860
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/27/2018 |
Decision Date | 01/08/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|