FDA product code CHH: Enzymatic Esterase--Oxidase, Cholesterol
CHH is the FDA product code for enzymatic esterase--oxidase, cholesterol. It is a Class I device, regulated under 21 CFR 862.1175 and reviewed by the Clinical Chemistry panel. FDA has cleared 230 510(k) submissions under CHH, 3 in the last five years, from 129 different applicants. The average 510(k) review took 87 days (median 50); 314 days on average over the last three years. FDA has posted 23 recalls for CHH devices, 4 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Enzymatic Esterase--Oxidase, Cholesterol |
| Device class | Class I |
| Regulation | 21 CFR 862.1175 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
510(k) clearances per year for CHH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 218 |
| 2018 | 2 | 88 |
| 2019 | 1 | 27 |
| 2022 | 1 | 568 |
| 2024 | 1 | 365 |
| 2025 | 1 | 264 |
Compare with all 510(k) review times · Search every CHH clearance
Top CHH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cholestech Corp. | 10 | 1995-02-22 |
| Em Diagnostic Systems, Inc. | 10 | 1993-12-16 |
| Polymer Technology Systems, Inc. | 7 | 2016-12-22 |
| Beckman Instruments, Inc. | 7 | 1997-06-11 |
| Boehringer Mannheim Corp. | 7 | 1996-03-06 |
124 more applicants have CHH clearances. See the full list in Caduvo.
Most recent CHH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251091 | Truvian Health | Lipids | 2025-12-30 | 264 |
| K232404 | Medicon Hellas S.A | CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES | 2024-08-09 | 365 |
| K203597 | Abbott Ireland Diagnostics Division | Cholesterol2 | 2022-06-30 | 568 |
| K190490 | Ortho-Clinical Diagnostics, Inc. | VITROS XT Chemistry Products TRIG-CHOL Slides | 2019-03-27 | 27 |
| K181373 | Laboratory Corporation of America Holdings | Extended Lipid Panel Assay | 2018-10-18 | 147 |
Recalls for CHH devices
23 product recalls in 20 recall events; 4 initiated in the last five years and 2 still open. Most recent: 2026-04-02.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2019 | 4 |
| 2021 | 2 |
| 2022 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code CHH?
CHH is the FDA product code for enzymatic esterase--oxidase, cholesterol. It is a Class I device, regulated under 21 CFR 862.1175 and reviewed by the Clinical Chemistry panel.
What device class is CHH?
Class I, regulation 21 CFR 862.1175. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CHH?
Across 230 cleared submissions the average was 87 days from receipt to decision (median 50).
Which companies have the most CHH clearances?
Cholestech Corp. (10); Em Diagnostic Systems, Inc. (10); Polymer Technology Systems, Inc. (7); Beckman Instruments, Inc. (7); Boehringer Mannheim Corp. (7).
Have CHH devices been recalled?
Yes: 23 product recalls across 20 recall events; the most recent began 2026-04-02.
Next steps
- Run an FDA pathway report with predicate devices for product code CHH
- Run a recall and safety report across every CHH manufacturer
- Watch product code CHH 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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