Apparatus, Perfusion
Perfusion Apparatus is a laboratory device used to circulate a controlled flow of culture medium, nutrients, or physiological fluid through an isolated tissue, organ, or cell culture system, maintaining viability and function during in vitro experimentation or laboratory diagnostic procedures. 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 KJH, 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
- KJH
- 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 |
|---|---|---|---|---|
| K875151 | ACUSYST-P/3X | Jan 12, 1988 | Substantially Equivalent | Endotronics, Inc. |
| K872086 | ACUSYST-JR | Jun 15, 1987 | Substantially Equivalent | Endotronics, Inc. |
| K864334 | ACUSYST-P (CELL CULTURE EQUIPMENT) | Nov 24, 1986 | Substantially Equivalent | Endotronics, Inc. |