Device Classification Name |
automated system for sample preparation and identification of microorganisms from cultured isolates by mass spectrometry
|
510(k) Number |
K191964 |
Device Name |
BD Kiestra IdentifA |
Applicant |
Becton, Dickinson and Company |
7 Loveton Circle, MC 964 |
Sparks,
MD
21152
|
|
Applicant Contact |
Janine Spafford |
Correspondent |
Becton, Dickinson and Company |
7 Loveton Circle, MC 964 |
Sparks,
MD
21152
|
|
Correspondent Contact |
Laura Stewart |
Regulation Number | 866.3378
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/23/2019 |
Decision Date | 11/03/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|