Device Classification Name |
Automated Multicolor Fluorescent Imaging Cytometric Analysis System
|
510(k) Number |
K150815 |
Device Name |
BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto CD4/Hb Cartridge Kit |
Applicant |
Becton, Dickinson and Company |
2350 Qume Dr. |
San Jose,
CA
95131
|
|
Applicant Contact |
Catherine(Katie) Bessette |
Correspondent |
Becton, Dickinson and Company |
2350 Qume Dr. |
San Jose,
CA
95131
|
|
Correspondent Contact |
Catherine(Katie) Bessette |
Regulation Number | 864.5220
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/27/2015 |
Decision Date | 12/17/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Immunology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|