Liquid Chromatography Columns 5-7070/71/72/73
FDA 510(k) K883615 · Supelco, Inc.
510(k) numberK883615
Submission
- Device name
- Liquid Chromatography Columns 5-7070/71/72/73
- Applicant
- Supelco, Inc.
Bellefonte, PA, US - Received
- August 24, 1988
- Decision date
- December 16, 1988
- 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 |
| 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 |
| K800061 | Bond Elut ColumnsDJY · Traditional | Analytichem International, Inc. | 03/12/1980SE |
More from Analytichem International, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K894141 | Liquid Chromatography ColumnsDPM · Traditional | 08/21/1989SE |
| K884403 | Liquid Chromatography Columns Solid Phase Ex. TubeDPM · Traditional | 12/22/1988SE |
| K881868 | Liquid Chromatography Columns Hisep Column & GuardDPM · Traditional | 08/29/1988SE |
| K881361 | Solid Phase Extraction TubesDJY · Traditional | 08/08/1988SE |
| K880724 | Liquid Chromato. ColumnsDPM · Traditional | 05/27/1988SE |
| K874824 | Capillary Columns for Gas ChromatographyDII · Traditional | 01/21/1988SE |
| K871174 | 4-9295 Barbiturates Test MixDKB · Traditional | 06/11/1987SE |
| K862542 | Capillary Columns for Gas ChromatographyDII · Traditional | 08/04/1986SE |
| K862541 | Liquid Chromatography ColumnsDPM · Traditional | 07/29/1986SE |
| K861633 | Liquid Chromatography ColumnsDPM · Traditional | 05/23/1986SE |
Questions and answers
When was Liquid Chromatography Columns 5-7070/71/72/73 cleared by the FDA?
Liquid Chromatography Columns 5-7070/71/72/73 (K883615) received a 510(k) decision of Substantially Equivalent on December 16, 1988, 114 days after the submission was received.
What is the product code of K883615?
The FDA product code is DJY – Ion-Exchange Chromatography, a Class I (low risk) device regulated under 21 CFR 862.2230.