KJH · Apparatus, Perfusion
Hematology · 21 CFR 864.2240 · Class 1
Overview
| Product Code | KJH |
|---|---|
| Device Name | Apparatus, Perfusion |
| Regulation | 21 CFR 864.2240 |
| Device Class | Class 1 |
| Review Panel | Hematology |
| GMP Exempt | Yes |
Identification
Cell and tissue culture supplies and equipment are devices that are used to examine, propagate, nourish, or grow cells and tissue cultures. These include such articles as slide culture chambers, perfusion and roller apparatus, cell culture suspension systems, and tissue culture flasks, disks, tubes, and roller bottles.
Classification Rationale
Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. If the devices are not labeled or otherwise represented as sterile, they are exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K875151 | ACUSYST-P/3X | Endotronics, Inc. | Jan 12, 1988 | SESE |
| K872086 | ACUSYST-JR | Endotronics, Inc. | Jun 15, 1987 | SESE |
| K864334 | ACUSYST-P (CELL CULTURE EQUIPMENT) | Endotronics, Inc. | Nov 24, 1986 | SESE |
Top Applicants
- Endotronics, Inc. — 3 clearances
