Capillary Columns for Gas Chromatography
FDA 510(k) K874824 · Supelco, Inc.
510(k) numberK874824
Submission
- Device name
- Capillary Columns for Gas Chromatography
- Applicant
- Supelco, Inc.
Bellefonte, PA, US - Received
- November 24, 1987
- Decision date
- January 21, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DII – Columns, Glc
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2250
- Specialty
- Clinical Chemistry
Other 510(k)s with product code DII
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K862542 | Capillary Columns for Gas ChromatographyDII · Traditional | Supelco, Inc. | 08/04/1986SE |
| K844164 | Reactifs, Ibf Ultrogels Aca & Ultrogels aDII · Traditional | Lkb Instruments, Inc. | 12/10/1984SE |
| K841712 | Capillary Gas Chromatographic ColumnsDII · Traditional | Supelco, Inc. | 05/21/1984SE |
| K791893 | 19091-XXXXX Ser. of Glass Capillary Col.DII · Traditional | Hewlett-Packard Co. | 10/30/1979SE |
More from Hewlett-Packard Co.
| 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 |
| 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 |
| 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 Capillary Columns for Gas Chromatography cleared by the FDA?
Capillary Columns for Gas Chromatography (K874824) received a 510(k) decision of Substantially Equivalent on January 21, 1988, 58 days after the submission was received.
What is the product code of K874824?
The FDA product code is DII – Columns, Glc, a Class I (low risk) device regulated under 21 CFR 862.2250.