FDA product code CFQ: Radioimmunoassay, Immunoglobulins (G, A, M)
CFQ is the FDA product code for radioimmunoassay, immunoglobulins (g, a, m). It is a Class II device, regulated under 21 CFR 866.5510 and reviewed by the Immunology panel. FDA has cleared 12 510(k) submissions under CFQ, from 5 different applicants. The average 510(k) review took 78 days (median 34).
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Immunoglobulins (G, A, M) |
| 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 CFQ clearance
Top CFQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| The Binding Site, Ltd. | 4 | 1999-11-24 |
| Dade Behring, Inc. | 3 | 1999-03-25 |
| Olympus America, Inc. | 3 | 1995-04-17 |
| Helena Laboratories | 1 | 1989-03-22 |
| Atlantic Antibodies | 1 | 1989-02-23 |
Most recent CFQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K981786 | The Binding Site, Ltd. | IGA MININEPH ANTISERUM | 1999-11-24 | 553 |
| K990551 | Dade Behring, Inc. | IGG FLEX REAGENT CARTRIDGE | 1999-03-25 | 31 |
| K990552 | Dade Behring, Inc. | IMMUNOGLOBULIN A TEST SYSTEM | 1999-03-25 | 31 |
| K990553 | Dade Behring, Inc. | IGM FLEX REAGENT CARTRIDGE | 1999-03-22 | 28 |
| K951055 | Olympus America, Inc. | OLYMPUS IGA IMMUNOTURBIDIMETRIC REAGENT | 1995-04-17 | 41 |
Recalls for CFQ devices
openFDA lists no recalls for product code CFQ.
Frequently asked questions
What is FDA product code CFQ?
CFQ is the FDA product code for radioimmunoassay, immunoglobulins (g, a, m). It is a Class II device, regulated under 21 CFR 866.5510 and reviewed by the Immunology panel.
What device class is CFQ?
Class II, regulation 21 CFR 866.5510. Typical premarket route: 510(k).
How long does a 510(k) take for product code CFQ?
Across 12 cleared submissions the average was 78 days from receipt to decision (median 34).
Which companies have the most CFQ clearances?
The Binding Site, Ltd. (4); Dade Behring, Inc. (3); Olympus America, Inc. (3); Helena Laboratories (1); Atlantic Antibodies (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CFQ
- Run a recall and safety report across every CFQ manufacturer
- Watch product code CFQ 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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