Apparatus, Roller
Roller Apparatus is a laboratory instrument used to rotate cylindrical tissue culture vessels, such as roller bottles, at a controlled speed, maintaining cells in suspension or promoting even distribution of medium over a large surface area to support large-scale cell culture production. 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 KJB, 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
- KJB
- 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 |
|---|---|---|---|---|
| K881466 | CELL-CULTURE SHAKER | Apr 18, 1988 | Substantially Equivalent | Cryodyne Technologies, Inc. |
| K872076 | CORNING DISPOSABLE ROLLER BOTTLES | Jun 15, 1987 | Substantially Equivalent | Corning Medical & Scientific |
| K852506 | BIOGLAS MICROCARRIER BEAD | Jul 12, 1985 | Substantially Equivalent | Solohill Engineering, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.