Device Classification Name |
Tubes, Vials, Systems, Serum Separators, Blood Collection
More FDA Info for this Device |
510(K) Number |
K230865 |
Device Name |
Tubes, Vials, Systems, Serum Separators, Blood Collection |
Applicant |
Becton Dickinson Infusion Therapy Systems, Inc.
9450 S State St
Sandy, UT 84070 US
Other 510(k) Applications for this Company
|
Contact |
Amy Moore
Other 510(k) Applications for this Contact |
Regulation Number |
862.1675
More FDA Info for this Regulation Number |
Classification Product Code |
JKA
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
03/29/2023 |
Decision Date |
09/28/2023 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
CH - Clinical Chemistry |
Review Advisory Committee |
HO - General Hospital |
Statement / Summary / Purged Status |
Summary |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|