Dish, Tissue Culture
Tissue Culture Dish is a flat, shallow container made of treated plastic or glass used in laboratory settings to maintain and grow cells or tissue explants in a liquid culture medium, providing a surface for cell attachment and access for nutrient exchange and microscopic observation. 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 KIZ, regulated under 21 CFR 864.2240, within the Hematology medical specialty. This device is exempt from Good Manufacturing Practice (GMP) regulations.
Basic Information
- Product Code
- KIZ
- 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 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K890542 | MULTIWELL CULTURE PLATE INSERTS | Feb 14, 1989 | Substantially Equivalent | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
| K873891 | TISSUE CULTURE DISHES | Nov 25, 1987 | Substantially Equivalent | NUNC, INC. |
| K871483 | TISSUE CULTURE/BACTERIOLOGICAL PETRI DISHES | Apr 29, 1987 | Substantially Equivalent | ISRATECH MARKETING CORP. |
| K854724 | CEKK-ADHESIVE MATRIX-MULTIPLE WELL PLATE CAM-PLATE | Dec 13, 1985 | Substantially Equivalent | LIFETRAC, INC. |
| K853634 | CORNING CELL WELLS-MULTIPLE WELL PLATES | Sep 16, 1985 | Substantially Equivalent | CORNING MEDICAL & SCIENTIFIC |
| K821687 | REMOVAWELL TISSUE CULTURE PLATE W/LID | Jun 24, 1982 | Substantially Equivalent | DYNATECH CORP. |
| K790958 | 120 WELL HISTO-PLATE | Jun 28, 1979 | Substantially Equivalent | DYNATECH LABORATORIES, INC. |
| K781792 | PRESSURIZER, EXETER CEMENT | Feb 08, 1979 | Substantially Equivalent | HOWMEDICA CORP. |
FEI Numbers
This FDA classification entry is associated with 70 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 70 registration numbers. Click on an entry to view related FDA registrations.