Product code KJG
- Device name
- Tube, Tissue Culture
- Medical specialty
- Pathology
- Device class
- 1
- Regulation number
- 864.3010
- Review panel
- PA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K823747 | 24 CELL WELLS TISSUE CULTURE | Corning Medical & Scientific | 1983-01-05 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10816203023985 | Accessories | ORIGEN BIOMEDICAL, INC. | 2025-06-18 |
| 10816203023978 | Accessories | ORIGEN BIOMEDICAL, INC. | 2025-06-18 |
| 10816203023961 | Accessories | ORIGEN BIOMEDICAL, INC. | 2025-06-18 |
| 10816203023947 | Accessories | ORIGEN BIOMEDICAL, INC. | 2025-06-18 |
| 10816203023886 | Accessories | ORIGEN BIOMEDICAL, INC. | 2025-06-18 |
| 10816203023879 | Accessories | ORIGEN BIOMEDICAL, INC. | 2025-06-18 |
| 10816203023862 | Accessories | ORIGEN BIOMEDICAL, INC. | 2025-06-18 |
| 10816203023855 | Accessories | ORIGEN BIOMEDICAL, INC. | 2025-06-18 |
| 10816203023848 | Accessories | ORIGEN BIOMEDICAL, INC. | 2025-06-18 |
| 10816203023442 | Accessories | ORIGEN BIOMEDICAL, INC. | 2024-12-06 |
| 10816203022827 | Accessories | ORIGEN BIOMEDICAL, INC. | 2024-12-06 |
| 10816203022209 | O-Wrap | ORIGEN BIOMEDICAL, INC. | 2023-04-03 |
| 10816203023435 | Accessories | ORIGEN BIOMEDICAL, INC. | 2018-08-14 |
| 10816203023312 | OriGen Biomedical | ORIGEN BIOMEDICAL, INC. | 2017-10-12 |
| 10816203023268 | Accessory Set | ORIGEN BIOMEDICAL, INC. | 2017-05-30 |
| 10816203023190 | Accessory Set | ORIGEN BIOMEDICAL, INC. | 2017-03-06 |
| 10816203023176 | Cell Connect | ORIGEN BIOMEDICAL, INC. | 2017-01-25 |
| 10816203022261 | Sterile Syringe | ORIGEN BIOMEDICAL, INC. | 2016-10-12 |
| 10816203020052 | Cell Connect | ORIGEN BIOMEDICAL, INC. | 2016-09-23 |
| 10816203023060 | Accessory Sets | ORIGEN BIOMEDICAL, INC. | 2016-09-23 |
| 10816203023053 | Accessory Sets | ORIGEN BIOMEDICAL, INC. | 2016-09-23 |
| 10816203023046 | Accessory Sets | ORIGEN BIOMEDICAL, INC. | 2016-09-23 |
| 10816203022438 | Accessory Set | ORIGEN BIOMEDICAL, INC. | 2016-09-23 |
| 10816203022186 | Tube Set | ORIGEN BIOMEDICAL, INC. | 2016-09-23 |
| 10816203022049 | Two 4-way stopcocks | ORIGEN BIOMEDICAL, INC. | 2016-09-23 |
| 10816203021707 | Protective Cap | ORIGEN BIOMEDICAL, INC. | 2016-09-23 |
| 10816203020618 | Tube Set Adapter | ORIGEN BIOMEDICAL, INC. | 2016-09-23 |
| 10816203020281 | Vial Spike with Needle-Free Valve | ORIGEN BIOMEDICAL, INC. | 2016-09-23 |
| 10816203020267 | Spike Adapter | ORIGEN BIOMEDICAL, INC. | 2016-09-23 |
| 10816203020069 | Cell Conect | ORIGEN BIOMEDICAL, INC. | 2016-09-23 |