FDA product code CHD: Acid, Ferric Ion-Sulfuric, Cholesterol
CHD is the FDA product code for acid, ferric ion-sulfuric, cholesterol. It is a Class I device, regulated under 21 CFR 862.1175 and reviewed by the Clinical Chemistry panel. FDA has cleared 3 510(k) submissions under CHD, from 3 different applicants. The average 510(k) review took 54 days (median 50).
Classification
| Field | Value |
|---|---|
| Device name | Acid, Ferric Ion-Sulfuric, Cholesterol |
| Device class | Class I |
| Regulation | 21 CFR 862.1175 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every CHD clearance
Top CHD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medical Specialties, Inc. | 1 | 1984-05-01 |
| American Monitor Corp. | 1 | 1983-04-05 |
| Omega Medical Electronics | 1 | 1982-07-13 |
Most recent CHD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K841052 | Medical Specialties, Inc. | CHOLESTEROL REAGENT SET | 1984-05-01 | 50 |
| K830616 | American Monitor Corp. | ACTIVATED URIC ACID | 1983-04-05 | 36 |
| K821195 | Omega Medical Electronics | CHOLESTEROL REAGENT SET | 1982-07-13 | 77 |
Recalls for CHD devices
openFDA lists no recalls for product code CHD.
Frequently asked questions
What is FDA product code CHD?
CHD is the FDA product code for acid, ferric ion-sulfuric, cholesterol. It is a Class I device, regulated under 21 CFR 862.1175 and reviewed by the Clinical Chemistry panel.
What device class is CHD?
Class I, regulation 21 CFR 862.1175. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CHD?
Across 3 cleared submissions the average was 54 days from receipt to decision (median 50).
Which companies have the most CHD clearances?
Medical Specialties, Inc. (1); American Monitor Corp. (1); Omega Medical Electronics (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CHD
- Run a recall and safety report across every CHD manufacturer
- Watch product code CHD 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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