FDA product code CDH: Acid, Uric, Phosphotungstate Reduction
CDH is the FDA product code for acid, uric, phosphotungstate reduction. It is a Class I device, regulated under 21 CFR 862.1775 and reviewed by the Clinical Chemistry panel. FDA has cleared 15 510(k) submissions under CDH, from 14 different applicants. The average 510(k) review took 45 days (median 50).
Classification
| Field | Value |
|---|---|
| Device name | Acid, Uric, Phosphotungstate Reduction |
| Device class | Class I |
| Regulation | 21 CFR 862.1775 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every CDH clearance
Top CDH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Volu Sol Medical Industries | 2 | 1979-12-07 |
| Dilab, Inc. | 1 | 1985-06-25 |
| Medical Specialties, Inc. | 1 | 1984-05-01 |
| Omega Medical Electronics | 1 | 1982-07-13 |
| American Monitor Corp. | 1 | 1981-11-16 |
9 more applicants have CDH clearances. See the full list in Caduvo.
Most recent CDH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K850933 | Dilab, Inc. | URIC ACID | 1985-06-25 | 110 |
| K841067 | Medical Specialties, Inc. | URIC ACID REAGENT SET | 1984-05-01 | 50 |
| K821213 | Omega Medical Electronics | URIC ACID REAGENT SET | 1982-07-13 | 77 |
| K813076 | American Monitor Corp. | PHOSPHOTUNGSTATE REDUCTION, URIC ACID | 1981-11-16 | 14 |
| K810088 | Bio-Analytics Laboratories, Inc. | URIC ACID (TPTZ) COLORINMETRIC | 1981-01-28 | 15 |
Recalls for CDH devices
openFDA lists no recalls for product code CDH.
Frequently asked questions
What is FDA product code CDH?
CDH is the FDA product code for acid, uric, phosphotungstate reduction. It is a Class I device, regulated under 21 CFR 862.1775 and reviewed by the Clinical Chemistry panel.
What device class is CDH?
Class I, regulation 21 CFR 862.1775. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CDH?
Across 15 cleared submissions the average was 45 days from receipt to decision (median 50).
Which companies have the most CDH clearances?
Volu Sol Medical Industries (2); Dilab, Inc. (1); Medical Specialties, Inc. (1); Omega Medical Electronics (1); American Monitor Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CDH
- Run a recall and safety report across every CDH manufacturer
- Watch product code CDH 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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