FDA product code JQX: Nephelometer, For Clinical Use
JQX is the FDA product code for nephelometer, for clinical use. It is a Class I device, regulated under 21 CFR 862.2700 and reviewed by the Clinical Chemistry panel. FDA has cleared 14 510(k) submissions under JQX, from 10 different applicants. The average 510(k) review took 42 days (median 34). FDA has posted 4 recalls for JQX devices.
Classification
| Field | Value |
|---|---|
| Device name | Nephelometer, For Clinical Use |
| Device class | Class I |
| Regulation | 21 CFR 862.2700 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JQX clearance
Top JQX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Beckman Instruments, Inc. | 2 | 1996-08-21 |
| Abbott Laboratories | 2 | 1985-04-30 |
| J.T. Baker Chemical Co. | 2 | 1980-07-21 |
| Biovation, Inc. | 2 | 1979-10-30 |
| Seradyn, Inc. | 1 | 1989-03-28 |
5 more applicants have JQX clearances. See the full list in Caduvo.
Most recent JQX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K962294 | Beckman Instruments, Inc. | IMMAGE IMMUNOCHEMISTRY SYSTEM | 1996-08-21 | 68 |
| K922273 | Beckman Instruments, Inc. | ARRAY(R) 360 | 1992-08-19 | 97 |
| K885263 | Seradyn, Inc. | QMS(TM) - THEOPHYLLINE | 1989-03-28 | 95 |
| K851253 | Abbott Laboratories | TDX ANALYZER W/NEPHELOMETRY CAROUSEL | 1985-04-30 | 33 |
| K851234 | Abbott Laboratories | A-JUST TURBIDITY METER | 1985-04-29 | 34 |
Recalls for JQX devices
4 product recalls in 4 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-06-01.
| Year | Recalls |
|---|---|
| 2017 | 1 |
Frequently asked questions
What is FDA product code JQX?
JQX is the FDA product code for nephelometer, for clinical use. It is a Class I device, regulated under 21 CFR 862.2700 and reviewed by the Clinical Chemistry panel.
What device class is JQX?
Class I, regulation 21 CFR 862.2700. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JQX?
Across 14 cleared submissions the average was 42 days from receipt to decision (median 34).
Which companies have the most JQX clearances?
Beckman Instruments, Inc. (2); Abbott Laboratories (2); J.T. Baker Chemical Co. (2); Biovation, Inc. (2); Seradyn, Inc. (1).
Have JQX devices been recalled?
Yes: 4 product recalls across 4 recall events; the most recent began 2017-06-01.
Next steps
- Run an FDA pathway report with predicate devices for product code JQX
- Run a recall and safety report across every JQX manufacturer
- Watch product code JQX 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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