Tox Perfect B Tubes and Reagents
FDA 510(k) K952501 · Chimera Research & Chemical, Inc.
510(k) numberK952501
Submission
- Device name
- Tox Perfect B Tubes and Reagents
- Applicant
- Chimera Research & Chemical, Inc.
Seminole, FL, US - Received
- May 30, 1995
- Decision date
- August 24, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|---|
| 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 |
| K881868 | Liquid Chromatography Columns Hisep Column & GuardDPM · Traditional | Supelco, Inc. | 08/29/1988SE |
| 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 |
|---|---|---|
| K970087 | CR PerfectCGX · Traditional | 03/06/1997SE |
| K951877 | Automated Analysis Assay for Bilirubin in UrineKQO · Traditional | 05/14/1996SE |
| K953393 | Tox Perfect a TubeDMP · Traditional | 10/06/1995SE |
| K950142 | CR PerfectCGX · Traditional | 05/25/1995SE |
| K940768 | Ad PerfectIFT · Traditional | 02/17/1995SE |
| K935408 | Ua PerfectKQO · Traditional | 06/13/1994SE |
Questions and answers
When was Tox Perfect B Tubes and Reagents cleared by the FDA?
Tox Perfect B Tubes and Reagents (K952501) received a 510(k) decision of Substantially Equivalent on August 24, 1995, 86 days after the submission was received.
What is the product code of K952501?
The FDA product code is DPM – Columns, Liquid Chromatography, a Class I (low risk) device regulated under 21 CFR 862.2260.