Device Classification Name |
Tubes, Vacuum Sample, With Anticoagulant
|
510(k) Number |
K230493 |
Device Name |
BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection Tube |
Applicant |
Becton Dickinson and Company |
1 Becton Drive |
Franklin Lakes,
NJ
07417
|
|
Applicant Contact |
Katherine Kenner Lemus |
Correspondent |
Becton Dickinson and Company |
1 Becton Drive |
Franklin Lakes,
NJ
07417
|
|
Correspondent Contact |
Katherine Kenner Lemus |
Regulation Number | 862.1675
|
Classification Product Code |
|
Date Received | 02/23/2023 |
Decision Date | 11/27/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Hematology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|