Du Pont Stericell Cell Culture System
FDA 510(k) K871324 · E.I. Dupont DE Nemours & Co., Inc.
510(k) numberK871324
Submission
- Device name
- Du Pont Stericell Cell Culture System
- Applicant
- E.I. Dupont DE Nemours & Co., Inc.
Wilmington, DE, US - Received
- April 3, 1987
- Decision date
- April 14, 1987
- 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 |
| 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 |
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| K953724 | Cronex Radiation Therapy CassetteIXA · Traditional | 09/06/1995SE |
| K951441 | Dupont Aca Digoxin (DGN a) MethodKXT · Traditional | 06/01/1995SE |
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| K950136 | Urine Opiates Screen Flex(Tm) Reagent CartridgeDJG · Traditional | 04/05/1995SE |
| K950135 | Urine Amphetamines Screen Flex(Tm) Reagent CartridgeDKZ · Traditional | 03/30/1995SE |
| K950427 | Urine Benzodiazepines Screen Flex Teagent CartridgeJXM · Traditional | 03/21/1995SE |
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Questions and answers
When was Du Pont Stericell Cell Culture System cleared by the FDA?
Du Pont Stericell Cell Culture System (K871324) received a 510(k) decision of Substantially Equivalent on April 14, 1987, 11 days after the submission was received.
What is the product code of K871324?
The FDA product code is KJA – Flask, Tissue Culture, a Class I (low risk) device regulated under 21 CFR 864.2240.