FDA product code JRQ: Shaker/Stirrer
JRQ is the FDA product code for shaker/stirrer. It is a Class I device, regulated under 21 CFR 862.2050 and reviewed by the Clinical Chemistry panel. FDA has cleared 8 510(k) submissions under JRQ, from 7 different applicants. The average 510(k) review took 32 days (median 25).
Classification
| Field | Value |
|---|---|
| Device name | Shaker/Stirrer |
| Device class | Class I |
| Regulation | 21 CFR 862.2050 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every JRQ clearance
Top JRQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| American Dade | 2 | 1981-11-24 |
| Dynatech Corp. | 1 | 1981-12-17 |
| Scientific Manufacturing Industries | 1 | 1980-06-09 |
| American Hospital Supply Corp. | 1 | 1979-06-28 |
| Sysmex Corp. | 1 | 1979-02-08 |
2 more applicants have JRQ clearances. See the full list in Caduvo.
Most recent JRQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K813318 | Dynatech Corp. | MINI-SHAKER | 1981-12-17 | 23 |
| K813148 | American Dade | S/P VORTEX MIXER | 1981-11-24 | 18 |
| K813149 | American Dade | S/P VORTEX MIXER JR. | 1981-11-24 | 18 |
| K801145 | Scientific Manufacturing Industries | SMI MULTI-TUBE VORTEXER | 1980-06-09 | 27 |
| K790753 | American Hospital Supply Corp. | DIMENSIONALL ROTATOR | 1979-06-28 | 72 |
Recalls for JRQ devices
openFDA lists no recalls for product code JRQ.
Frequently asked questions
What is FDA product code JRQ?
JRQ is the FDA product code for shaker/stirrer. It is a Class I device, regulated under 21 CFR 862.2050 and reviewed by the Clinical Chemistry panel.
What device class is JRQ?
Class I, regulation 21 CFR 862.2050. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JRQ?
Across 8 cleared submissions the average was 32 days from receipt to decision (median 25).
Which companies have the most JRQ clearances?
American Dade (2); Dynatech Corp. (1); Scientific Manufacturing Industries (1); American Hospital Supply Corp. (1); Sysmex Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JRQ
- Run a recall and safety report across every JRQ manufacturer
- Watch product code JRQ 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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