FDA product code CGO: Lieberman-Burchard/Abell-Kendall, Colorimetric, Cholesterol
CGO is the FDA product code for lieberman-burchard/abell-kendall, colorimetric, cholesterol. It is a Class I device, regulated under 21 CFR 862.1175 and reviewed by the Clinical Chemistry panel. FDA has cleared 11 510(k) submissions under CGO, from 11 different applicants. The average 510(k) review took 42 days (median 35).
Classification
| Field | Value |
|---|---|
| Device name | Lieberman-Burchard/Abell-Kendall, Colorimetric, 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 CGO clearance
Top CGO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dilab, Inc. | 1 | 1985-06-25 |
| King Diagnostics, Inc. | 1 | 1981-07-10 |
| Anco Medical Reagents & Assoc. | 1 | 1981-01-26 |
| Diagnostic Solutions, Inc. | 1 | 1980-05-28 |
| Fisher Scientific Co., LLC | 1 | 1978-10-24 |
6 more applicants have CGO clearances. See the full list in Caduvo.
Most recent CGO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K850938 | Dilab, Inc. | CHOLESTEROL | 1985-06-25 | 110 |
| K811747 | King Diagnostics, Inc. | KING DIAGNOSTICS CHOLESTEROL TEST | 1981-07-10 | 18 |
| K810090 | Anco Medical Reagents & Assoc. | CHOLESTEROL REAGENT | 1981-01-26 | 13 |
| K800682 | Diagnostic Solutions, Inc. | REAGENTS FOR DETERM. CHOLESTEROL/SERUM | 1980-05-28 | 63 |
| K781611 | Fisher Scientific Co., LLC | CHOLESTEROL DET. IN SERUM | 1978-10-24 | 35 |
Recalls for CGO devices
openFDA lists no recalls for product code CGO.
Frequently asked questions
What is FDA product code CGO?
CGO is the FDA product code for lieberman-burchard/abell-kendall, colorimetric, cholesterol. It is a Class I device, regulated under 21 CFR 862.1175 and reviewed by the Clinical Chemistry panel.
What device class is CGO?
Class I, regulation 21 CFR 862.1175. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CGO?
Across 11 cleared submissions the average was 42 days from receipt to decision (median 35).
Which companies have the most CGO clearances?
Dilab, Inc. (1); King Diagnostics, Inc. (1); Anco Medical Reagents & Assoc. (1); Diagnostic Solutions, Inc. (1); Fisher Scientific Co., LLC (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CGO
- Run a recall and safety report across every CGO manufacturer
- Watch product code CGO 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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