FDA product code CHQ: Chromatographic/Fluorometric Method, Catecholamines
CHQ is the FDA product code for chromatographic/fluorometric method, catecholamines. It is a Class I device, regulated under 21 CFR 862.1165 and reviewed by the Clinical Chemistry panel. FDA has cleared 10 510(k) submissions under CHQ, from 5 different applicants. The average 510(k) review took 97 days (median 82).
Classification
| Field | Value |
|---|---|
| Device name | Chromatographic/Fluorometric Method, Catecholamines |
| Device class | Class I |
| Regulation | 21 CFR 862.1165 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every CHQ clearance
Top CHQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Esa, Inc. | 3 | 2004-01-30 |
| Bioanalytical Systems, Inc. | 3 | 1997-08-04 |
| Bio-Rad | 2 | 1989-10-25 |
| Ibl GmbH | 1 | 2005-10-03 |
| Whale Scientific, Inc. | 1 | 1986-03-14 |
Most recent CHQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K051969 | Ibl GmbH | TRICAT RIA (ADRENALIN/NORADRENALIN/DOPAMINE); KATCOMBI RIA (ADRENALIN/NORADRENALIN); NORADRENALIN RIA | 2005-10-03 | 75 |
| K032199 | Esa, Inc. | ESA PLASMA FREE METANEPHRINE ANALYSIS KIT | 2004-01-30 | 196 |
| K972167 | Bioanalytical Systems, Inc. | PLASMA CATECHOLAMINE KIT | 1997-08-04 | 56 |
| K963938 | Esa, Inc. | MODEL 5500 CEAS | 1996-12-26 | 86 |
| K952919 | Bioanalytical Systems, Inc. | URINARY METANEPHRINE KIT | 1995-09-06 | 72 |
Recalls for CHQ devices
openFDA lists no recalls for product code CHQ.
Frequently asked questions
What is FDA product code CHQ?
CHQ is the FDA product code for chromatographic/fluorometric method, catecholamines. It is a Class I device, regulated under 21 CFR 862.1165 and reviewed by the Clinical Chemistry panel.
What device class is CHQ?
Class I, regulation 21 CFR 862.1165. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CHQ?
Across 10 cleared submissions the average was 97 days from receipt to decision (median 82).
Which companies have the most CHQ clearances?
Esa, Inc. (3); Bioanalytical Systems, Inc. (3); Bio-Rad (2); Ibl GmbH (1); Whale Scientific, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CHQ
- Run a recall and safety report across every CHQ manufacturer
- Watch product code CHQ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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