Tissue Culture Flask
FDA 510(k) K864021 · Fenwal Laboratories
510(k) numberK864021
Submission
- Device name
- Tissue Culture Flask
- Applicant
- Fenwal Laboratories
Round Lake, IL, US - Received
- October 15, 1986
- Decision date
- October 29, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KJA – Flask, Tissue Culture
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.2240
- Specialty
- Hematology
Other 510(k)s with product code KJA
| 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 |
| 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 |
Questions and answers
When was Tissue Culture Flask cleared by the FDA?
Tissue Culture Flask (K864021) received a 510(k) decision of Substantially Equivalent on October 29, 1986, 14 days after the submission was received.
What is the product code of K864021?
The FDA product code is KJA – Flask, Tissue Culture, a Class I (low risk) device regulated under 21 CFR 864.2240.