KIZ · Dish, Tissue Culture
Hematology · 21 CFR 864.2240 · Class 1
Overview
| Product Code | KIZ |
|---|---|
| Device Name | Dish, Tissue 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 (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K890542 | MULTIWELL CULTURE PLATE INSERTS | Bd Becton Dickinson Vacutainer Systems Preanalytic | Feb 14, 1989 | SESE |
| K873891 | TISSUE CULTURE DISHES | Nunc, Inc. | Nov 25, 1987 | SESE |
| K871483 | TISSUE CULTURE/BACTERIOLOGICAL PETRI DISHES | Isratech Marketing Corp. | Apr 29, 1987 | SESE |
| K854724 | CEKK-ADHESIVE MATRIX-MULTIPLE WELL PLATE CAM-PLATE | Lifetrac, Inc. | Dec 13, 1985 | SESE |
| K853634 | CORNING CELL WELLS-MULTIPLE WELL PLATES | Corning Medical & Scientific | Sep 16, 1985 | SESE |
| K821687 | REMOVAWELL TISSUE CULTURE PLATE W/LID | Dynatech Corp. | Jun 24, 1982 | SESE |
| K790958 | 120 WELL HISTO-PLATE | Dynatech Laboratories, Inc. | Jun 28, 1979 | SESE |
| K781792 | PRESSURIZER, EXETER CEMENT | Howmedica Corp. | Feb 8, 1979 | SESE |
Top Applicants
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
- Corning Medical & Scientific — 1 clearance
- Dynatech Corp. — 1 clearance
- Dynatech Laboratories, Inc. — 1 clearance
- Howmedica Corp. — 1 clearance
