Device Classification Name |
Tubes, Vials, Systems, Serum Separators, Blood Collection
More FDA Info for this Device |
510(K) Number |
K223810 |
Device Name |
Tubes, Vials, Systems, Serum Separators, Blood Collection |
Applicant |
SB-Kawasumi Laboratories, Inc.
3-25-4 Tonomachi, Kawasaki-Ku
Kawasaki-Shi 210-8602 JP
Other 510(k) Applications for this Company
|
Contact |
Shiro Agehama
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 |
12/20/2022 |
Decision Date |
02/24/2023 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
CH - Clinical Chemistry |
Review Advisory Committee |
HO - General Hospital |
Statement / Summary / Purged Status |
Summary |
Type |
Special |
Reviewed By Third Party |
N |
Expedited Review |
|