CHQ — Chromatographic/Fluorometric Method, Catecholamines Class I
FDA product code CHQ covers "Chromatographic/Fluorometric Method, Catecholamines", a Class I medical device regulated under 21 CFR 862.1165. Submissions are reviewed by the Clinical Chemistry panel. At least 10 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- CHQ
- Device Class
- Class I
- Regulation Number
- 862.1165
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K051969 | ibl | TRICAT RIA (ADRENALIN/NORADRENALIN/DOPAMINE); KATCOMBI RIA (ADRENALIN/NORADRENAL | October 3, 2005 |
| K032199 | esa | ESA PLASMA FREE METANEPHRINE ANALYSIS KIT | January 30, 2004 |
| K972167 | bioanalytical systems | PLASMA CATECHOLAMINE KIT | August 4, 1997 |
| K963938 | esa | MODEL 5500 CEAS | December 26, 1996 |
| K952919 | bioanalytical systems | URINARY METANEPHRINE KIT | September 6, 1995 |
| K943099 | bioanalytical systems | URINARY CATECHOLAMINE KIT | October 7, 1994 |
| K931148 | esa | MODEL 5500 COULOCHEM ELECTRODE ARRAY SYSTEM | June 9, 1993 |
| K894966 | bio-rad | PLASMA CATECHOLAMINES BY HPLC | October 25, 1989 |
| K873371 | bio-rad | URINARY FREE CATECHOLAMINES & METANEPHRINES (HPLC) | January 5, 1988 |
| K855214 | whale scientific | CAT-3 CATECHOLAMINE ASSAY KIT | March 14, 1986 |