Dupont Prep Type Si Extraciton Cartridge
FDA 510(k) K850963 · E.I. Dupont DE Nemours & Co., Inc.
510(k) numberK850963
Submission
- Device name
- Dupont Prep Type Si Extraciton Cartridge
- Applicant
- E.I. Dupont DE Nemours & Co., Inc.
Wilmington, DE, US - Received
- March 8, 1985
- Decision date
- March 25, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DJY – Ion-Exchange Chromatography
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2230
- Specialty
- Clinical Chemistry
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|---|---|---|---|
| K890113 | The Cdi(R) System 400DJY · Traditional | Cardiovascular Devices, Inc. | 05/23/1989SE |
| K883615 | Liquid Chromatography Columns 5-7070/71/72/73DJY · Traditional | Supelco, Inc. | 12/16/1988SE |
| K881361 | Solid Phase Extraction TubesDJY · Traditional | Supelco, Inc. | 08/08/1988SE |
| K840985 | Trisacryl GF 05 & Trisacryl GF 2000DJY · Traditional | Lkb Instruments, Inc. | 04/19/1984SE |
| K832198 | HC40/HC75 Prepacked ColumsDJY · Traditional | Hamilton Co. | 08/12/1983SE |
| K831289 | Prefilled Iec ColumnsDJY · Traditional | Berwick Medical Products, Inc. | 06/16/1983SE |
| K830693 | Dupont Prep Type AS Extraction CartrideDJY · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 04/05/1983SE |
| K830692 | Dupont Prep Od Extraction CartrideDJY · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 04/05/1983SE |
| K823697 | Prep Type a Extraction CartridgeDJY · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 01/05/1983SE |
| K800061 | Bond Elut ColumnsDJY · Traditional | Analytichem International, Inc. | 03/12/1980SE |
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Questions and answers
When was Dupont Prep Type Si Extraciton Cartridge cleared by the FDA?
Dupont Prep Type Si Extraciton Cartridge (K850963) received a 510(k) decision of Substantially Equivalent on March 25, 1985, 17 days after the submission was received.
What is the product code of K850963?
The FDA product code is DJY – Ion-Exchange Chromatography, a Class I (low risk) device regulated under 21 CFR 862.2230.