FDA product code CZW: Complement C3, Antigen, Antiserum, Control
CZW is the FDA product code for complement c3, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5240 and reviewed by the Immunology panel. FDA has cleared 44 510(k) submissions under CZW, from 36 different applicants. The average 510(k) review took 84 days (median 46). FDA has posted 1 recall for CZW devices.
Classification
| Field | Value |
|---|---|
| Device name | Complement C3, Antigen, Antiserum, Control |
| Device class | Class II |
| Regulation | 21 CFR 866.5240 |
| 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 CZW clearance
Top CZW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dade Behring, Inc. | 3 | 2006-09-22 |
| Dako Corp. | 3 | 1987-04-21 |
| The Binding Site, Ltd. | 2 | 1999-12-20 |
| Instrumentation Laboratory CO | 2 | 1996-09-25 |
| Behring Diagnostics, Inc. | 2 | 1996-02-21 |
31 more applicants have CZW clearances. See the full list in Caduvo.
Most recent CZW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K100179 | The Binding Site Group , Ltd. | SPAPLUS | 2010-08-13 | 204 |
| K063150 | Thermo Electron OY | COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL | 2007-03-19 | 154 |
| K061852 | Dade Behring, Inc. | DIMENSION VISTA C3 AND C4 FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL LOW, MEDIUM, HIGH | 2006-09-22 | 84 |
| K050665 | Dade Behring, Inc. | N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4) | 2005-05-02 | 48 |
| K042494 | Ortho-Clinical Diagnostics | VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMANCE VERIFIERS I, II, AND III | 2004-10-19 | 35 |
Recalls for CZW devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-05-16.
| Year | Recalls |
|---|---|
| 2018 | 1 |
Frequently asked questions
What is FDA product code CZW?
CZW is the FDA product code for complement c3, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5240 and reviewed by the Immunology panel.
What device class is CZW?
Class II, regulation 21 CFR 866.5240. Typical premarket route: 510(k).
How long does a 510(k) take for product code CZW?
Across 44 cleared submissions the average was 84 days from receipt to decision (median 46).
Which companies have the most CZW clearances?
Dade Behring, Inc. (3); Dako Corp. (3); The Binding Site, Ltd. (2); Instrumentation Laboratory CO (2); Behring Diagnostics, Inc. (2).
Have CZW devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2018-05-16.
Next steps
- Run an FDA pathway report with predicate devices for product code CZW
- Run a recall and safety report across every CZW manufacturer
- Watch product code CZW 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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