FDA product code JQW: Station, Pipetting And Diluting, For Clinical Use
JQW is the FDA product code for station, pipetting and diluting, for clinical use. It is a Class I device, regulated under 21 CFR 862.2750 and reviewed by the Clinical Chemistry panel. FDA has cleared 140 510(k) submissions under JQW, from 74 different applicants. The average 510(k) review took 62 days (median 48). FDA has posted 36 recalls for JQW devices.
Classification
| Field | Value |
|---|---|
| Device name | Station, Pipetting And Diluting, For Clinical Use |
| Device class | Class I |
| Regulation | 21 CFR 862.2750 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JQW clearance
Top JQW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Denley Instruments, Inc. | 8 | 1992-11-05 |
| Dynatech Laboratories, Inc. | 7 | 1988-06-07 |
| Hamilton Co. | 6 | 1996-08-16 |
| Micromedic Systems | 6 | 1984-04-19 |
| Diagnostic Products Corp. | 5 | 1993-01-26 |
69 more applicants have JQW clearances. See the full list in Caduvo.
Most recent JQW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K023955 | Becton, Dickinson & CO | BD VIPER INSTRUMENT | 2003-06-24 | 209 |
| K973335 | Zenyx Scientific , Ltd. | QUATRO SP SAMPLE PROCESSING SYSTEMS (200-499, INCLUSIVE) | 1998-04-30 | 238 |
| K980180 | Waters Corporation | 2700 SAMPLE MANAGER | 1998-02-12 | 23 |
| K970420 | Pharmacia, Inc. | MASTERCAP AM 5.0/MASTERCAP RM 5.0 | 1997-06-30 | 147 |
| K970616 | Cavro Scientific Instruments, Inc. | MINI SAMPLER PROCESSOR | 1997-04-21 | 62 |
Recalls for JQW devices
36 product recalls in 29 recall events; 0 initiated in the last five years and 1 still open. Most recent: 2021-01-15.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2018 | 1 |
| 2019 | 1 |
| 2021 | 1 |
Frequently asked questions
What is FDA product code JQW?
JQW is the FDA product code for station, pipetting and diluting, for clinical use. It is a Class I device, regulated under 21 CFR 862.2750 and reviewed by the Clinical Chemistry panel.
What device class is JQW?
Class I, regulation 21 CFR 862.2750. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JQW?
Across 140 cleared submissions the average was 62 days from receipt to decision (median 48).
Which companies have the most JQW clearances?
Denley Instruments, Inc. (8); Dynatech Laboratories, Inc. (7); Hamilton Co. (6); Micromedic Systems (6); Diagnostic Products Corp. (5).
Have JQW devices been recalled?
Yes: 36 product recalls across 29 recall events; the most recent began 2021-01-15.
Next steps
- Run an FDA pathway report with predicate devices for product code JQW
- Run a recall and safety report across every JQW manufacturer
- Watch product code JQW 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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