Product code CHQ
- Device name
- Chromatographic/Fluorometric Method, Catecholamines
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.1165
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K051969 | TRICAT RIA (ADRENALIN/NORADRENALIN/DOPAMINE); KATCOMBI RIA (ADRENALIN/NORADRENALIN); NORADRENALIN RIA | Ibl GmbH | 2005-10-03 |
| K032199 | ESA PLASMA FREE METANEPHRINE ANALYSIS KIT | Esa, Inc. | 2004-01-30 |
| K972167 | PLASMA CATECHOLAMINE KIT | Bioanalytical Systems, Inc. | 1997-08-04 |
| K963938 | MODEL 5500 CEAS | Esa, Inc. | 1996-12-26 |
| K952919 | URINARY METANEPHRINE KIT | Bioanalytical Systems, Inc. | 1995-09-06 |
| K943099 | URINARY CATECHOLAMINE KIT | Bioanalytical Systems, Inc. | 1994-10-07 |
| K931148 | MODEL 5500 COULOCHEM ELECTRODE ARRAY SYSTEM | Esa, Inc. | 1993-06-09 |
| K894966 | PLASMA CATECHOLAMINES BY HPLC | Bio-Rad | 1989-10-25 |
| K873371 | URINARY FREE CATECHOLAMINES & METANEPHRINES (HPLC) | Bio-Rad | 1988-01-05 |
| K855214 | CAT-3 CATECHOLAMINE ASSAY KIT | Whale Scientific, Inc. | 1986-03-14 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04250317557070 | Reagent | Chromsystems Instruments + Chemicals GmbH | 2025-06-20 |
| 04250317557087 | Reagent | Chromsystems Instruments + Chemicals GmbH | 2025-06-20 |
| 04250317557506 | Reagent Kit | Chromsystems Instruments + Chemicals GmbH | 2025-06-20 |
| 04250317557513 | Basic Kit | Chromsystems Instruments + Chemicals GmbH | 2025-06-20 |
| 04250317557544 | Reagent Kit | Chromsystems Instruments + Chemicals GmbH | 2025-06-20 |
| 04250317557551 | Basic Kit | Chromsystems Instruments + Chemicals GmbH | 2025-06-20 |
| 04250317557568 | Reagent Kit | Chromsystems Instruments + Chemicals GmbH | 2025-06-20 |
| 04250317557575 | Reagent Kit | Chromsystems Instruments + Chemicals GmbH | 2025-06-20 |
| 04250317557582 | Basic Kit | Chromsystems Instruments + Chemicals GmbH | 2025-06-20 |
| 04250317557599 | Basic Kit | Chromsystems Instruments + Chemicals GmbH | 2025-06-20 |
| 00404847419085 | Adrenaline ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2021-06-07 |
| 00404847427486 | Metanephrine (Urine) ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2021-06-07 |
| 00404847431759 | Catcombi ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2021-06-07 |
| 04250317503268 | Accessorie | Chromsystems Instruments + Chemicals GmbH | 2020-08-31 |
| 04250317526366 | Reagent | Chromsystems Instruments + Chemicals GmbH | 2020-08-31 |
| 04250317503275 | Accessorie | Chromsystems Instruments + Chemicals GmbH | 2020-08-31 |
| 04250317503299 | Reagent | Chromsystems Instruments + Chemicals GmbH | 2020-08-31 |
| 04250317519276 | Reagent | Chromsystems Instruments + Chemicals GmbH | 2020-08-31 |
| 04250317526359 | Reagent | Chromsystems Instruments + Chemicals GmbH | 2020-08-31 |
| 04250317503244 | Reagent | Chromsystems Instruments + Chemicals GmbH | 2020-08-31 |
| 04250317503220 | Reagent | Chromsystems Instruments + Chemicals GmbH | 2020-08-31 |
| 04250317503213 | Reagent | Chromsystems Instruments + Chemicals GmbH | 2020-08-31 |
| 04250317503190 | Reagent | Chromsystems Instruments + Chemicals GmbH | 2020-08-31 |
| 04250317502957 | Accessorie | Chromsystems Instruments + Chemicals GmbH | 2020-08-31 |
| 04250317503169 | Reagent | Chromsystems Instruments + Chemicals GmbH | 2020-08-28 |
| 04250317503138 | Reagent | Chromsystems Instruments + Chemicals GmbH | 2020-08-28 |
| 04250317503145 | Reagent | Chromsystems Instruments + Chemicals GmbH | 2020-08-28 |
| 04250317503084 | Reagent | Chromsystems Instruments + Chemicals GmbH | 2020-08-28 |
| 04250317546463 | Reagent | Chromsystems Instruments + Chemicals GmbH | 2020-08-27 |
| 04250317546449 | Reagent | Chromsystems Instruments + Chemicals GmbH | 2020-08-27 |