CGO
11 FDA 510(k) clearances · Product code
35 daysmedian time to decision
63 days90th percentile
11clearances measured
FDA profile
- Official device name
- Lieberman-Burchard/Abell-Kendall, Colorimetric, Cholesterol
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1175
- Medical specialty
- Clinical Chemistry
- Adverse events (MAUDE)
- 1994: 1 · 2002: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| CHOLESTEROL (K850938) | Dilab, Inc. | 1985-06-25 |
| KING DIAGNOSTICS CHOLESTEROL TEST (K811747) | King Diagnostics, Inc. | 1981-07-10 |
| CHOLESTEROL REAGENT (K810090) | Anco Medical Reagents & Assoc. | 1981-01-26 |
| REAGENTS FOR DETERM. CHOLESTEROL/SERUM (K800682) | Diagnostic Solutions, Inc. | 1980-05-28 |
| CHOLESTEROL DET. IN SERUM (K781611) | Fisher Scientific Co., LLC | 1978-10-24 |
| SR-PLUS DIRECT CHOLESTEROL TEST (K780545) | Stanbio Laboratory | 1978-05-26 |
| ALPHA/CHOL (K772043) | Standard Scientific, Inc. | 1977-11-28 |
| CHOLESTEROL (K771833) | Gamma Enterprises, Inc. | 1977-10-18 |
| CHOLESTEROL REAGENT (K771313) | Mallinckrodt Critical Care | 1977-08-03 |
| UNIPAK CHOLESTEROL (K771093) | Harleco | 1977-07-21 |
| CHOLESTEROL PROCEDURE, TEKPOINT TOTAL (K770457) | Icn Pharmaceuticals, Inc. | 1977-05-03 |
Track CGO automatically
Every clearance here is in the API, with alerts when new ones post.