The Cdi(R) System 400
FDA 510(k) K890113 · Cardiovascular Devices, Inc.
510(k) numberK890113
Submission
- Device name
- The Cdi(R) System 400
- Applicant
- Cardiovascular Devices, Inc.
Irvine, CA, US - Received
- January 11, 1989
- Decision date
- May 23, 1989
- 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 |
|---|---|---|---|
| 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 |
| K800061 | Bond Elut ColumnsDJY · Traditional | Analytichem International, Inc. | 03/12/1980SE |
More from Analytichem International, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K884228 | Cdi(R) 2000 Blood Gas MonitorCBZ · Traditional | 01/30/1989SE |
| K871221 | Cdi(Tm) Extracorporeal Blood Gas System 300DRY · Traditional | 06/05/1987SE |
| K864703 | Modified Gas-Stat(Tm) Monitoring SystemDTY · Traditional | 02/19/1987SE |
| K843912 | Intravascular Blood Gas SystemCCE · Traditional | 01/10/1985SE |
| K840749 | Gast Stat Monitoring SystemDTY · Traditional | 04/17/1984SE |
| K831225 | Gas-Stat Monitoring SystemDRY · Traditional | 05/27/1983SE |
| K822000 | Extracorporeal Blood Gas SystemDTY · Traditional | 12/22/1982SE |
Questions and answers
When was The Cdi(R) System 400 cleared by the FDA?
The Cdi(R) System 400 (K890113) received a 510(k) decision of Substantially Equivalent on May 23, 1989, 132 days after the submission was received.
What is the product code of K890113?
The FDA product code is DJY – Ion-Exchange Chromatography, a Class I (low risk) device regulated under 21 CFR 862.2230.