Flask, Tissue Culture
FDA product code KJA · Class I (low risk) · 21 CFR 864.2240 · Hematology
13510(k) clearances
0PMA approvals
1recalls
GMP exemptexempt from GMP rules
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K972404 | Vacutainer Brand Safety Blood Collection Assembly(Multiple)KJA · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 07/22/1997SE |
| K933228 | Kapton Peel PouchKJA · Traditional | American Fluoroseal Corp. | 03/30/1994SE |
| K885121 | Cell ScraperKJA · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 12/28/1988SE |
| K873890 | Tissue Culture FlasksKJA · Traditional | Nunc, Inc. | 11/25/1987SE |
| K873889 | Tissue Culture TubesKJA · Traditional | Nunc, Inc. | 11/25/1987SE |
| K871324 | Du Pont Stericell Cell Culture SystemKJA · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 04/14/1987SE |
| K870865 | Tissue Culture BagKJA · Traditional | American Fluoroseal Corp. | 03/30/1987SE |
| K864021 | Tissue Culture FlaskKJA · Traditional | Fenwal Laboratories | 10/29/1986SE |
| K862152 | Tissue Culture Flask PL 732 Plastic Accessory ProdKJA · Traditional | Travenol Laboratories, S.A. | 06/16/1986SE |
| K861253 | Tissue Culture Flask PL 732 PlasticKJA · Traditional | Travenol Laboratories, S.A. | 04/11/1986SE |
| K853441 | Fetal Bovine Serum in Transfer ContainerKJA · Traditional | Newport Biosystems, Inc. | 08/26/1985SE |
| K852532 | Newport Media Transfer ContainerKJA · Traditional | Newport Bio Systems | 08/22/1985SE |
| K823138 | Cell ScraperKJA · Traditional | Corning Costar Corp. | 11/29/1982SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1409-2021 Class III | Evolve Cell Culture Bags, part numbers: EV1000N and EV3000N The Evolve bag is made of…It was identified that tissue culture bags were incorrectly labeled as free of phthalates. | OriGen Biomedical, Inc. | 01/28/2021Terminated |