FDA Product Code
FDA Product Code KSR — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.9100
510(k) Clearances — 16 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K032827 | KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501 | Tyco Healthcare | 2003-12-08 | Traditional | PDF ↗ |
| K020753 | DEROYAL SURGICAL, UMBILICUP | Deroyal | 2002-06-13 | Traditional | PDF ↗ |
| K810500 | BLOOD FREEZING BAG | Delmed, Inc. | 1981-09-23 | Traditional | PDF ↗ |
| K810897 | ALPHA PLASTIC PLASMA BOTTLE | Alpha Therapeutic Corp. | 1981-09-23 | Traditional | PDF ↗ |
| K811523 | PLASMA FLEX | Terumo America, Inc. | 1981-09-09 | Traditional | PDF ↗ |
| K811449 | HAEMONETICS 1000ML COMPONENT BAG | Haemonetics Corp. | 1981-07-01 | Traditional | PDF ↗ |
| K810711 | HAEMONETICS 600 ML. COMPONENT BAG | Haemonetics Corp. | 1981-05-08 | Traditional | PDF ↗ |
| K810313 | HAEMONETICS 1400 ML THERAPEUTIC BAG | Haemonetics Corp. | 1981-03-31 | Traditional | PDF ↗ |
| K801082 | GAMBRO HEMOFREEZE-BAG | Gambro, Inc. | 1980-10-31 | Traditional | PDF ↗ |
| K801219 | PLASMAPOOLER | North American Biologicals, Inc. | 1980-10-31 | Traditional | PDF ↗ |
| K792395 | PHARMAFLEX CRYOGENIC BAG | Pharmachem Corp. | 1980-02-26 | Traditional | PDF ↗ |
| K792185 | PIASMA SAFE | Cry-O-Safe, Inc. | 1979-12-28 | Traditional | PDF ↗ |
| K791673 | EMPTY TRANSFER BAG | Delmed, Inc. | 1979-10-23 | Traditional | PDF ↗ |
| K781811 | TRANSFER PAK 4R 9006 | Travenol Laboratories, S.A. | 1978-11-08 | Traditional | PDF ↗ |
| K780354 | CRYOCYTE PACK | Travenol Laboratories, S.A. | 1978-06-14 | Traditional | PDF ↗ |
| K760952 | TERASAKI LYMPHOCYTE TRANSPORT KIT | Dravon Medical, Inc. | 1977-01-17 | Traditional | PDF ↗ |
Product code KSR · Class II · Hematology. Data: openFDA.