FDA product code CZS: Retinol-Binding Protein, Antigen, Antiserum, Control
CZS is the FDA product code for retinol-binding protein, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5765 and reviewed by the Immunology panel. FDA has cleared 3 510(k) submissions under CZS, from 2 different applicants. The average 510(k) review took 47 days (median 35).
Classification
| Field | Value |
|---|---|
| Device name | Retinol-Binding Protein, Antigen, Antiserum, Control |
| Device class | Class I |
| Regulation | 21 CFR 866.5765 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every CZS clearance
Top CZS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| The Binding Site, Ltd. | 2 | 1997-09-29 |
| Behring Diagnostics, Inc. | 1 | 1985-08-22 |
Most recent CZS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K973189 | The Binding Site, Ltd. | RETINOL BINDING PROTEIN RBP RID KIT | 1997-09-29 | 35 |
| K955881 | The Binding Site, Ltd. | RETINOL BINDING RID KIT | 1996-03-22 | 85 |
| K853261 | Behring Diagnostics, Inc. | LASER RBP LASER(RETINOL BINDING PROTEIN REAGENTS) | 1985-08-22 | 20 |
Recalls for CZS devices
openFDA lists no recalls for product code CZS.
Frequently asked questions
What is FDA product code CZS?
CZS is the FDA product code for retinol-binding protein, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5765 and reviewed by the Immunology panel.
What device class is CZS?
Class I, regulation 21 CFR 866.5765. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CZS?
Across 3 cleared submissions the average was 47 days from receipt to decision (median 35).
Which companies have the most CZS clearances?
The Binding Site, Ltd. (2); Behring Diagnostics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CZS
- Run a recall and safety report across every CZS manufacturer
- Watch product code CZS 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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