Product code KJF
- Device name
- System, Suspension, Cell Culture
- Medical specialty
- Hematology
- Device class
- 1
- Regulation number
- 864.2240
- Review panel
- PA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K893787 | LIFECELL RECOVERY CONTAINER | Baxter Healthcare Corp | 1989-06-23 |
| K892645 | AMICON VITAFIBER FLO-PATH BIORECT/VLS CELL CULT SY | Amicon, Inc. | 1989-06-13 |
| K875221 | TOOTH PRESERVING SYSTEM | Biological Rescue Products, Inc. | 1988-04-14 |
| K780305 | CELL | Dynatech Laboratories, Inc. | 1978-03-27 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00850019717174 | G-Rex | WILSON WOLF MANUFACTURING CORPORATION | 2022-11-14 |
| 00850019717150 | G-Rex | WILSON WOLF MANUFACTURING CORPORATION | 2022-10-12 |
| 00850019717129 | G-Rex | WILSON WOLF MANUFACTURING CORPORATION | 2022-09-14 |
| 00850019717037 | G-Rex | WILSON WOLF MANUFACTURING CORPORATION | 2022-09-13 |
| 00850019717068 | G-Rex | WILSON WOLF MANUFACTURING CORPORATION | 2022-09-12 |
| 00850019717198 | G-Rex | WILSON WOLF MANUFACTURING CORPORATION | 2022-08-08 |
| 00850019717136 | G-Rex | WILSON WOLF MANUFACTURING CORPORATION | 2022-07-27 |
| 00817827027055 | EXP-PAK | CHARTER MEDICAL, LTD. | 2021-08-23 |
| 00817827027048 | EXP-PAK | CHARTER MEDICAL, LTD. | 2021-08-23 |
| 00817827027031 | EXP-PAK | CHARTER MEDICAL, LTD. | 2021-08-23 |
| 00817827027024 | EXP-PAK | CHARTER MEDICAL, LTD. | 2021-08-23 |
| 00817827027017 | EXP-PAK | CHARTER MEDICAL, LTD. | 2021-08-23 |
| 08720299213623 | 1L Bottle | Scinus Cell Expansion Netherlands B.V. | 2021-01-14 |
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