Bond Elut Columns
FDA 510(k) K800061 · Analytichem International, Inc.
510(k) numberK800061
Submission
- Device name
- Bond Elut Columns
- Applicant
- Analytichem International, Inc.
Mchenry, IL, US - Received
- January 9, 1980
- Decision date
- March 12, 1980
- 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
Other 510(k)s with product code DJY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K850963 | Dupont Prep Type Si Extraciton CartridgeDJY · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 03/25/1985SE |
| 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 |
More from E.I. Dupont DE Nemours & Co., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K781728 | ExtubeKEA · Traditional | 12/20/1978SE |
Questions and answers
When was Bond Elut Columns cleared by the FDA?
Bond Elut Columns (K800061) received a 510(k) decision of Substantially Equivalent on March 12, 1980, 63 days after the submission was received.
What is the product code of K800061?
The FDA product code is DJY – Ion-Exchange Chromatography, a Class I (low risk) device regulated under 21 CFR 862.2230.