FDA product code CZN: Iga, Fitc, Antigen, Antiserum, Control
CZN is the FDA product code for iga, fitc, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5510 and reviewed by the Immunology panel. FDA has cleared 7 510(k) submissions under CZN, from 6 different applicants. The average 510(k) review took 62 days (median 35).
Classification
| Field | Value |
|---|---|
| Device name | Iga, Fitc, 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 CZN clearance
Top CZN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Gelco Diagnostics, Inc. | 2 | 1983-10-31 |
| Helena Laboratories | 1 | 1989-04-12 |
| Kallestad Laboratories, Inc. | 1 | 1986-02-26 |
| Miles Laboratories, Inc. | 1 | 1984-06-01 |
| Dako Corp. | 1 | 1983-07-18 |
1 more applicants have CZN clearances. See the full list in Caduvo.
Most recent CZN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K891683 | Helena Laboratories | TITAN GEL IFE FREE KAPPA/LAMBA LIGHT CHAIN ANTISER | 1989-04-12 | 21 |
| K855011 | Kallestad Laboratories, Inc. | QUANTIMETRIC PLUS C3 REAGENT KIT | 1986-02-26 | 72 |
| K841815 | Miles Laboratories, Inc. | OPTIMATE IGA TEST | 1984-06-01 | 31 |
| K832262 | Gelco Diagnostics, Inc. | FITC GOAT ANTI-HUMAN IMMUNOGLOBULINS | 1983-10-31 | 123 |
| K832257 | Gelco Diagnostics, Inc. | GOAT ANTI-HUMAN IGA A CHAIN SPECIFIC | 1983-10-28 | 120 |
Recalls for CZN devices
openFDA lists no recalls for product code CZN.
Frequently asked questions
What is FDA product code CZN?
CZN is the FDA product code for iga, fitc, 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 CZN?
Class II, regulation 21 CFR 866.5510. Typical premarket route: 510(k).
How long does a 510(k) take for product code CZN?
Across 7 cleared submissions the average was 62 days from receipt to decision (median 35).
Which companies have the most CZN clearances?
Gelco Diagnostics, Inc. (2); Helena Laboratories (1); Kallestad Laboratories, Inc. (1); Miles Laboratories, Inc. (1); Dako Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CZN
- Run a recall and safety report across every CZN manufacturer
- Watch product code CZN 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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