FDA product code DHC: System, Test, Systemic Lupus Erythematosus
DHC is the FDA product code for system, test, systemic lupus erythematosus. It is a Class II device, regulated under 21 CFR 866.5820 and reviewed by the Immunology panel. FDA has cleared 16 510(k) submissions under DHC, from 13 different applicants. The average 510(k) review took 71 days (median 40). FDA has posted 1 recall for DHC devices.
Classification
| Field | Value |
|---|---|
| Device name | System, Test, Systemic Lupus Erythematosus |
| Device class | Class II |
| Regulation | 21 CFR 866.5820 |
| 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 DHC clearance
Top DHC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Corgenix, Inc. | 2 | 2001-04-09 |
| Icl Scientific | 2 | 1981-02-09 |
| Cordis Corp. | 2 | 1980-05-08 |
| Elias U.S.A., Inc. | 1 | 1993-03-10 |
| The Binding Site, Ltd. | 1 | 1993-03-10 |
8 more applicants have DHC clearances. See the full list in Caduvo.
Most recent DHC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K001352 | Corgenix, Inc. | REAADS IGG ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT | 2001-04-09 | 346 |
| K001398 | Corgenix, Inc. | REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT | 2001-03-30 | 331 |
| K930421 | Elias U.S.A., Inc. | ELIAS DSDNA ABS | 1993-03-10 | 43 |
| K930247 | The Binding Site, Ltd. | HUMAN A-DS DNA EIA KIT FOR DIAGNOSTIC USE | 1993-03-10 | 50 |
| K914801 | General Biometrics, Inc. | IMMUNOWELL DSDNA ANTIBODY TEST | 1991-12-09 | 46 |
Recalls for DHC devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2009-07-14.
Frequently asked questions
What is FDA product code DHC?
DHC is the FDA product code for system, test, systemic lupus erythematosus. It is a Class II device, regulated under 21 CFR 866.5820 and reviewed by the Immunology panel.
What device class is DHC?
Class II, regulation 21 CFR 866.5820. Typical premarket route: 510(k).
How long does a 510(k) take for product code DHC?
Across 16 cleared submissions the average was 71 days from receipt to decision (median 40).
Which companies have the most DHC clearances?
Corgenix, Inc. (2); Icl Scientific (2); Cordis Corp. (2); Elias U.S.A., Inc. (1); The Binding Site, Ltd. (1).
Have DHC devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2009-07-14.
Next steps
- Run an FDA pathway report with predicate devices for product code DHC
- Run a recall and safety report across every DHC manufacturer
- Watch product code DHC 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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