FDA product code CZJ: Igd, Antigen, Antiserum, Control
CZJ is the FDA product code for igd, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5510 and reviewed by the Immunology panel. FDA has cleared 8 510(k) submissions under CZJ, from 6 different applicants. The average 510(k) review took 87 days (median 70).
Classification
| Field | Value |
|---|---|
| Device name | Igd, Antigen, Antiserum, Control |
| Device class | Class II |
| Regulation | 21 CFR 866.5510 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every CZJ clearance
Top CZJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| The Binding Site, Ltd. | 3 | 2005-11-23 |
| The Binding Site | 1 | 2009-12-28 |
| Kallestad Diag, A Div. of Erbamont, Inc. | 1 | 1988-09-22 |
| Helena Laboratories | 1 | 1987-08-12 |
| Kent Laboratories, Inc. | 1 | 1983-07-18 |
1 more applicants have CZJ clearances. See the full list in Caduvo.
Most recent CZJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K092450 | The Binding Site | HUMAN IGD KIT FOR USE ON SPAPLUS | 2009-12-28 | 140 |
| K051299 | The Binding Site, Ltd. | IGD DIAGNOSTIC TEST KITS | 2005-11-23 | 189 |
| K002561 | The Binding Site, Ltd. | SHEEP ANTI-HUMAN IGD IMMUNOFIXATION GRADE KIT | 2000-10-26 | 70 |
| K913671 | The Binding Site, Ltd. | HUMAN IGD IMMUNOLOGICAL NL TEST KIT | 1991-12-02 | 105 |
| K883001 | Kallestad Diag, A Div. of Erbamont, Inc. | QM300 CALIBRATOR D PACK | 1988-09-22 | 66 |
Recalls for CZJ devices
openFDA lists no recalls for product code CZJ.
Frequently asked questions
What is FDA product code CZJ?
CZJ is the FDA product code for igd, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5510 and reviewed by the Immunology panel.
What device class is CZJ?
Class II, regulation 21 CFR 866.5510. Typical premarket route: 510(k).
How long does a 510(k) take for product code CZJ?
Across 8 cleared submissions the average was 87 days from receipt to decision (median 70).
Which companies have the most CZJ clearances?
The Binding Site, Ltd. (3); The Binding Site (1); Kallestad Diag, A Div. of Erbamont, Inc. (1); Helena Laboratories (1); Kent Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CZJ
- Run a recall and safety report across every CZJ manufacturer
- Watch product code CZJ 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