Bottle, Roller, Tissue Culture
Roller Tissue Culture Bottle is a cylindrical laboratory vessel used in conjunction with a roller apparatus to culture cells over a large internal surface area, enabling scalable production of cells or cell-derived products by maintaining cells in a rotating liquid medium 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 KJC, regulated under 21 CFR 864.2240, within the Hematology medical specialty. This device is exempt from Good Manufacturing Practice (GMP) regulations.
Basic Information
- Product Code
- KJC
- 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 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K880509 | MULTISURFACE ROLLER BOTTLE (M.S.R.B.) | Apr 01, 1988 | Substantially Equivalent | MOTIL PLASTICS LTD. |
| K873137 | IN VITRO 2.5X ROLLER BOTTLE | Aug 24, 1987 | Substantially Equivalent | IN VITRO SCIENTIFIC PRODUCTS |
| K791049 | SYNALON ROLLER BOTTLE | Jun 28, 1979 | Substantially Equivalent | DYNATECH LABORATORIES, INC. |
FEI Numbers
This FDA classification entry is associated with 17 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 17 registration numbers. Click on an entry to view related FDA registrations.