KJF · System, Suspension, Cell Culture
Hematology · 21 CFR 864.2240 · Class 1
Overview
| Product Code | KJF |
|---|---|
| Device Name | System, Suspension, Cell Culture |
| 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 (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K893787 | LIFECELL RECOVERY CONTAINER | Baxter Healthcare Corp | Jun 23, 1989 | SESE |
| K892645 | AMICON VITAFIBER FLO-PATH BIORECT/VLS CELL CULT SY | Amicon, Inc. | Jun 13, 1989 | SESE |
| K875221 | TOOTH PRESERVING SYSTEM | Biological Rescue Products, Inc. | Apr 14, 1988 | SESE |
| K780305 | CELL | Dynatech Laboratories, Inc. | Mar 27, 1978 | SESE |
Top Applicants
- Amicon, Inc. — 1 clearance
- Baxter Healthcare Corp — 1 clearance
- Biological Rescue Products, Inc. — 1 clearance
- Dynatech Laboratories, Inc. — 1 clearance
