Liquid Chromatography Columns Hisep Column & Guard
FDA 510(k) K881868 · Supelco, Inc.
510(k) numberK881868
Submission
- Device name
- Liquid Chromatography Columns Hisep Column & Guard
- Applicant
- Supelco, Inc.
Bellefonte, PA, US - Received
- May 3, 1988
- Decision date
- August 29, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DPM – Columns, Liquid Chromatography
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2260
- Specialty
- Clinical Chemistry
Other 510(k)s with product code DPM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K952501 | Tox Perfect B Tubes and ReagentsDPM · Traditional | Chimera Research & Chemical, Inc. | 08/24/1995SE |
| K895105 | High Pressure Inert Plastic Columns for Clin. UseDPM · Traditional | Waters Chemical Products | 10/06/1989SE |
| K894141 | Liquid Chromatography ColumnsDPM · Traditional | Supelco, Inc. | 08/21/1989SE |
| K891673 | Advanced Purification Glass ColumnDPM · Traditional | Waters Chemical Products | 04/26/1989SE |
| K884403 | Liquid Chromatography Columns Solid Phase Ex. TubeDPM · Traditional | Supelco, Inc. | 12/22/1988SE |
| K880724 | Liquid Chromato. ColumnsDPM · Traditional | Supelco, Inc. | 05/27/1988SE |
| K864267 | Sep-Pak Cartridges (Liquid Chromatography)DPM · Traditional | Millipore Corp. | 01/09/1987SE |
| K862541 | Liquid Chromatography ColumnsDPM · Traditional | Supelco, Inc. | 07/29/1986SE |
| K861633 | Liquid Chromatography ColumnsDPM · Traditional | Supelco, Inc. | 05/23/1986SE |
| K842909 | Liquid Chromatography Columns;Ion ExchDPM · Traditional | Supelco, Inc. | 10/05/1984SE |
More from Supelco, 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 |
| K883615 | Liquid Chromatography Columns 5-7070/71/72/73DJY · Traditional | 12/16/1988SE |
| 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 Hisep Column & Guard cleared by the FDA?
Liquid Chromatography Columns Hisep Column & Guard (K881868) received a 510(k) decision of Substantially Equivalent on August 29, 1988, 118 days after the submission was received.
What is the product code of K881868?
The FDA product code is DPM – Columns, Liquid Chromatography, a Class I (low risk) device regulated under 21 CFR 862.2260.