FDA product code KJF: System, Suspension, Cell Culture
KJF is the FDA product code for system, suspension, cell culture. It is a Class I device, regulated under 21 CFR 864.2240 and reviewed by the Pathology panel. FDA has cleared 4 510(k) submissions under KJF, from 4 different applicants. The average 510(k) review took 60 days (median 47).
Classification
| Field | Value |
|---|---|
| Device name | System, Suspension, Cell Culture |
| Device class | Class I |
| Regulation | 21 CFR 864.2240 |
| Review panel | PA — Pathology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every KJF clearance
Top KJF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Baxter Healthcare Corp | 1 | 1989-06-23 |
| Amicon, Inc. | 1 | 1989-06-13 |
| Biological Rescue Products, Inc. | 1 | 1988-04-14 |
| Dynatech Laboratories, Inc. | 1 | 1978-03-27 |
Most recent KJF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K893787 | Baxter Healthcare Corp | LIFECELL RECOVERY CONTAINER | 1989-06-23 | 32 |
| K892645 | Amicon, Inc. | AMICON VITAFIBER FLO-PATH BIORECT/VLS CELL CULT SY | 1989-06-13 | 62 |
| K875221 | Biological Rescue Products, Inc. | TOOTH PRESERVING SYSTEM | 1988-04-14 | 114 |
| K780305 | Dynatech Laboratories, Inc. | CELL | 1978-03-27 | 32 |
Recalls for KJF devices
openFDA lists no recalls for product code KJF.
Frequently asked questions
What is FDA product code KJF?
KJF is the FDA product code for system, suspension, cell culture. It is a Class I device, regulated under 21 CFR 864.2240 and reviewed by the Pathology panel.
What device class is KJF?
Class I, regulation 21 CFR 864.2240. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KJF?
Across 4 cleared submissions the average was 60 days from receipt to decision (median 47).
Which companies have the most KJF clearances?
Baxter Healthcare Corp (1); Amicon, Inc. (1); Biological Rescue Products, Inc. (1); Dynatech Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KJF
- Run a recall and safety report across every KJF manufacturer
- Watch product code KJF for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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