FDA product code JZQ: Plates And Equipment, Radial Immunodiffusion
JZQ is the FDA product code for plates and equipment, radial immunodiffusion. It is a Class I device, regulated under 21 CFR 866.4800 and reviewed by the Immunology panel. FDA has cleared 7 510(k) submissions under JZQ, from 7 different applicants. The average 510(k) review took 36 days (median 28). FDA has posted 1 recall for JZQ devices.
Classification
| Field | Value |
|---|---|
| Device name | Plates And Equipment, Radial Immunodiffusion |
| Device class | Class I |
| Regulation | 21 CFR 866.4800 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JZQ clearance
Top JZQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| The Binding Site, Ltd. | 1 | 1988-06-08 |
| Dynatech Laboratories, Inc. | 1 | 1988-04-21 |
| Calbiochem-Behring Corp. | 1 | 1983-07-28 |
| Meridian Diagnostics, Inc. | 1 | 1980-01-24 |
| Helena Laboratories | 1 | 1979-05-23 |
2 more applicants have JZQ clearances. See the full list in Caduvo.
Most recent JZQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K881174 | The Binding Site, Ltd. | RID PLATE READER | 1988-06-08 | 82 |
| K881675 | Dynatech Laboratories, Inc. | IMMULON 4 FLAT BOTTOM PLATES & REMOVAWELL STRIPS | 1988-04-21 | 3 |
| K831811 | Calbiochem-Behring Corp. | REVOLUTION RADIAL IMMUNODIFFUSION PLATE | 1983-07-28 | 52 |
| K792699 | Meridian Diagnostics, Inc. | OUCHTERLONY AGAR PLATES | 1980-01-24 | 28 |
| K790646 | Helena Laboratories | HELENA QUIPLATE SYSTEM | 1979-05-23 | 54 |
Recalls for JZQ devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2012-10-09.
Frequently asked questions
What is FDA product code JZQ?
JZQ is the FDA product code for plates and equipment, radial immunodiffusion. It is a Class I device, regulated under 21 CFR 866.4800 and reviewed by the Immunology panel.
What device class is JZQ?
Class I, regulation 21 CFR 866.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JZQ?
Across 7 cleared submissions the average was 36 days from receipt to decision (median 28).
Which companies have the most JZQ clearances?
The Binding Site, Ltd. (1); Dynatech Laboratories, Inc. (1); Calbiochem-Behring Corp. (1); Meridian Diagnostics, Inc. (1); Helena Laboratories (1).
Have JZQ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2012-10-09.
Next steps
- Run an FDA pathway report with predicate devices for product code JZQ
- Run a recall and safety report across every JZQ manufacturer
- Watch product code JZQ 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.
All Immunology product codes · FDA product code lookup · 510(k) database search · 510(k) review times