Panels › Hematology › Product code KSR · Class 2
Container, Empty, For Collection & Processing Of Blood & Blood Components
Regulation 864.9100
0510(k)s in 12 months (16 all time)
0recalls in 12 months (4 all time)
3recalls that name a 510(k)
Top companies in KSR
| Company | 510(k)s | Recalls |
|---|---|---|
| Haemonetics Corp. | 3 | 0 |
| Becton Dickinson & Company | 0 | 2 |
| Delmed, Inc. | 2 | 0 |
| DeRoyal Industries Inc | 0 | 2 |
| Travenol Laboratories, S.A. | 2 | 0 |
| Alpha Therapeutic Corp. | 1 | 0 |
| Cry-O-Safe, Inc. | 1 | 0 |
| Deroyal | 1 | 0 |
| Dravon Medical, Inc. | 1 | 0 |
| Gambro, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 8, 2003 | K032827 | KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501 Tyco Healthcare | KSR |
| Jun 13, 2002 | K020753 | DEROYAL SURGICAL, UMBILICUP Deroyal | KSR |
| Sep 23, 1981 | K810897 | ALPHA PLASTIC PLASMA BOTTLE Alpha Therapeutic Corp. | KSR |
| Sep 23, 1981 | K810500 | BLOOD FREEZING BAG Delmed, Inc. | KSR |
| Sep 9, 1981 | K811523 | PLASMA FLEX Terumo America, Inc. | KSR |
| Jul 1, 1981 | K811449 | HAEMONETICS 1000ML COMPONENT BAG Haemonetics Corp. | KSR |
| May 8, 1981 | K810711 | HAEMONETICS 600 ML. COMPONENT BAG Haemonetics Corp. | KSR |
| Mar 31, 1981 | K810313 | HAEMONETICS 1400 ML THERAPEUTIC BAG Haemonetics Corp. | KSR |
| Oct 31, 1980 | K801219 | PLASMAPOOLER North American Biologicals, Inc. | KSR |
| Oct 31, 1980 | K801082 | GAMBRO HEMOFREEZE-BAG Gambro, Inc. | KSR |
| Feb 26, 1980 | K792395 | PHARMAFLEX CRYOGENIC BAG Pharmachem Corp. | KSR |
| Dec 28, 1979 | K792185 | PIASMA SAFE Cry-O-Safe, Inc. | KSR |
| Oct 23, 1979 | K791673 | EMPTY TRANSFER BAG Delmed, Inc. | KSR |
| Nov 8, 1978 | K781811 | TRANSFER PAK 4R 9006 Travenol Laboratories, S.A. | KSR |
| Jun 14, 1978 | K780354 | CRYOCYTE PACK Travenol Laboratories, S.A. | KSR |
| Jan 17, 1977 | K760952 | TERASAKI LYMPHOCYTE TRANSPORT KIT Dravon Medical, Inc. | KSR |
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