FDA product code DIH: Colorimetry, Cholinesterase
DIH is the FDA product code for colorimetry, cholinesterase. It is a Class I device, regulated under 21 CFR 862.3240 and reviewed by the Clinical Toxicology panel. FDA has cleared 26 510(k) submissions under DIH, from 22 different applicants. The average 510(k) review took 127 days (median 69). FDA has posted 5 recalls for DIH devices, 4 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Colorimetry, Cholinesterase |
| Device class | Class I |
| Regulation | 21 CFR 862.3240 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) exempt |
Top DIH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sclavo, Inc. | 3 | 1989-01-27 |
| Eastman Kodak Company | 2 | 1991-08-26 |
| Sigma Diagnostics, Inc. | 2 | 1986-09-17 |
| Beckman Coulter, Inc. | 1 | 2011-02-07 |
| Roche Diagnostics Corp. | 1 | 2006-07-03 |
17 more applicants have DIH clearances. See the full list in Caduvo.
Most recent DIH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K103373 | Beckman Coulter, Inc. | SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722 | 2011-02-07 | 82 |
| K061093 | Roche Diagnostics Corp. | CHOLINESTERASE GEN.2 TEST SYSTEM | 2006-07-03 | 75 |
| K051444 | Sentinel Ch. Srl | SENTINEL CHOLINESTERASE LIQUID | 2005-06-20 | 18 |
| K030045 | Olympus America, Inc. | OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114) | 2003-02-21 | 46 |
| K023992 | Wiener Laboratories Saic | WIENER LAB COLINESTERASA AA | 2003-02-12 | 72 |
Recalls for DIH devices
5 product recalls in 2 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2025-06-10.
| Year | Recalls |
|---|---|
| 2025 | 4 |
Frequently asked questions
What is FDA product code DIH?
DIH is the FDA product code for colorimetry, cholinesterase. It is a Class I device, regulated under 21 CFR 862.3240 and reviewed by the Clinical Toxicology panel.
What device class is DIH?
Class I, regulation 21 CFR 862.3240. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DIH?
Across 26 cleared submissions the average was 127 days from receipt to decision (median 69).
Which companies have the most DIH clearances?
Sclavo, Inc. (3); Eastman Kodak Company (2); Sigma Diagnostics, Inc. (2); Beckman Coulter, Inc. (1); Roche Diagnostics Corp. (1).
Have DIH devices been recalled?
Yes: 5 product recalls across 2 recall events; the most recent began 2025-06-10.
Next steps
- Run an FDA pathway report with predicate devices for product code DIH
- Run a recall and safety report across every DIH manufacturer
- Watch product code DIH 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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