System, Suspension, Cell Culture
Cell Culture Suspension System is a laboratory device or system designed to maintain cells in a uniform suspension within a culture vessel, providing controlled agitation, aeration, or other physical conditions that support the viability and growth of suspension-adapted cells in an in vitro environment. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, meaning it does not require premarket notification or approval. The product code is KJF, regulated under 21 CFR 864.2240, within the Hematology medical specialty. This device is exempt from Good Manufacturing Practice (GMP) regulations.
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Basic Information
- Product Code
- KJF
- Device Class
- FDA class 1
- Regulation Number
- 864.2240
- Medical Specialty
- Hematology
- Review Panel
- PA
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K893787 | LIFECELL RECOVERY CONTAINER | Jun 23, 1989 | Substantially Equivalent | Baxter Healthcare Corp |
| K892645 | AMICON VITAFIBER FLO-PATH BIORECT/VLS CELL CULT SY | Jun 13, 1989 | Substantially Equivalent | Amicon, Inc. |
| K875221 | TOOTH PRESERVING SYSTEM | Apr 14, 1988 | Substantially Equivalent | Biological Rescue Products, Inc. |
| K780305 | CELL | Mar 27, 1978 | Substantially Equivalent | Dynatech Laboratories, Inc. |
FEI Numbers
This FDA classification entry is associated with 23 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 23 registration numbers. Click on an entry to view related FDA registrations.