FDA product code CZX: Hemopexin, Antigen, Antiserum, Control
CZX is the FDA product code for hemopexin, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5490 and reviewed by the Immunology panel. FDA has cleared 3 510(k) submissions under CZX, from 3 different applicants. The average 510(k) review took 60 days (median 20).
Classification
| Field | Value |
|---|---|
| Device name | Hemopexin, Antigen, Antiserum, Control |
| Device class | Class II |
| Regulation | 21 CFR 866.5490 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every CZX clearance
Top CZX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| J.T. Baker Chemical Co. | 1 | 1980-07-08 |
| Kent Laboratories, Inc. | 1 | 1979-09-04 |
| Kallestad Laboratories, Inc. | 1 | 1978-02-28 |
Most recent CZX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K801432 | J.T. Baker Chemical Co. | HEMOPEXIN NEPHELOMETRIC ASSAY | 1980-07-08 | 20 |
| K790713 | Kent Laboratories, Inc. | ANTISERUM TO HUMAN HEMOPEXIN | 1979-09-04 | 145 |
| K780250 | Kallestad Laboratories, Inc. | HEMOPEXIN NEPHELOMETRIC ASSAYS | 1978-02-28 | 14 |
Recalls for CZX devices
openFDA lists no recalls for product code CZX.
Frequently asked questions
What is FDA product code CZX?
CZX is the FDA product code for hemopexin, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5490 and reviewed by the Immunology panel.
What device class is CZX?
Class II, regulation 21 CFR 866.5490. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CZX?
Across 3 cleared submissions the average was 60 days from receipt to decision (median 20).
Which companies have the most CZX clearances?
J.T. Baker Chemical Co. (1); Kent Laboratories, Inc. (1); Kallestad Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CZX
- Run a recall and safety report across every CZX manufacturer
- Watch product code CZX 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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