KSR · Class II · 21 CFR 864.9100

FDA Product Code KSR: Container, Empty, For Collection & Processing Of Blood & Blood Components

Leading manufacturers include Haemonetics Corp., Delmed, Inc. and Travenol Laboratories, S.A..

16
Total
16
Cleared
97d
Avg days
1977
Since

FDA 510(k) Cleared Container, Empty, For Collection & Processing Of Blood & Blood Components Devices (Product Code KSR)

16 devices
1–16 of 16
Cleared Sep 23, 1981
BLOOD FREEZING BAG
K810500
Delmed, Inc.
Hematology · 211d
Cleared Sep 09, 1981
PLASMA FLEX
K811523
Terumo America, Inc.
Chemistry · 103d
Cleared Jul 01, 1981
HAEMONETICS 1000ML COMPONENT BAG
K811449
Haemonetics Corp.
Hematology · 40d
Cleared May 08, 1981
HAEMONETICS 600 ML. COMPONENT BAG
K810711
Haemonetics Corp.
Hematology · 52d
Cleared Mar 31, 1981
HAEMONETICS 1400 ML THERAPEUTIC BAG
K810313
Haemonetics Corp.
Hematology · 54d
Cleared Oct 31, 1980
GAMBRO HEMOFREEZE-BAG
K801082
Gambro, Inc.
Hematology · 177d
Cleared Oct 23, 1979
EMPTY TRANSFER BAG
K791673
Delmed, Inc.
Hematology · 56d
Cleared Nov 08, 1978
TRANSFER PAK 4R 9006
K781811
Travenol Laboratories, S.A.
Hematology · 13d
Cleared Jun 14, 1978
CRYOCYTE PACK
K780354
Travenol Laboratories, S.A.
Hematology · 103d

About Product Code KSR - Regulatory Context