FDA product code DEW: Igg, Antigen, Antiserum, Control
DEW is the FDA product code for igg, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5510 and reviewed by the Immunology panel. FDA has cleared 76 510(k) submissions under DEW, from 49 different applicants. The average 510(k) review took 58 days (median 40). FDA has posted 4 recalls for DEW devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Igg, 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 DEW clearance
Top DEW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kent Laboratories, Inc. | 5 | 1979-09-04 |
| Beckman Instruments, Inc. | 4 | 1997-03-06 |
| Dako Corp. | 4 | 1986-08-25 |
| Icl Scientific | 4 | 1981-05-08 |
| Helena Laboratories | 3 | 2001-03-15 |
44 more applicants have DEW clearances. See the full list in Caduvo.
Most recent DEW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K050113 | Roche Diagnostics Corp. | TINA-QUANT IGG GEN.2 | 2005-02-08 | 21 |
| K040434 | Roche Diagnostics Corp. | ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2 | 2004-03-10 | 20 |
| K010617 | Helena Laboratories | SPIFE IFE CALIBRATOR AND CONTROL KIT | 2001-03-15 | 14 |
| K993928 | Wako Chemicals USA, Inc. | WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD | 2000-01-18 | 61 |
| K993281 | Kamiya Biomedical Co. | K-ASSAY IGG | 1999-11-09 | 40 |
Recalls for DEW devices
4 product recalls in 4 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-07-31.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code DEW?
DEW is the FDA product code for igg, 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 DEW?
Class II, regulation 21 CFR 866.5510. Typical premarket route: 510(k).
How long does a 510(k) take for product code DEW?
Across 76 cleared submissions the average was 58 days from receipt to decision (median 40).
Which companies have the most DEW clearances?
Kent Laboratories, Inc. (5); Beckman Instruments, Inc. (4); Dako Corp. (4); Icl Scientific (4); Helena Laboratories (3).
Have DEW devices been recalled?
Yes: 4 product recalls across 4 recall events; the most recent began 2024-07-31.
Next steps
- Run an FDA pathway report with predicate devices for product code DEW
- Run a recall and safety report across every DEW manufacturer
- Watch product code DEW 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.
All Immunology product codes · FDA product code lookup · 510(k) database search · 510(k) review times