FDA Product Code
FDA Product Code CGO — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1175
510(k) Clearances — 11 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K850938 | CHOLESTEROL | Dilab, Inc. | 1985-06-25 | Traditional | PDF ↗ |
| K811747 | KING DIAGNOSTICS CHOLESTEROL TEST | King Diagnostics, Inc. | 1981-07-10 | Traditional | PDF ↗ |
| K810090 | CHOLESTEROL REAGENT | Anco Medical Reagents & Assoc. | 1981-01-26 | Traditional | PDF ↗ |
| K800682 | REAGENTS FOR DETERM. CHOLESTEROL/SERUM | Diagnostic Solutions, Inc. | 1980-05-28 | Traditional | PDF ↗ |
| K781611 | CHOLESTEROL DET. IN SERUM | Fisher Scientific Co., LLC | 1978-10-24 | Traditional | PDF ↗ |
| K780545 | SR-PLUS DIRECT CHOLESTEROL TEST | Stanbio Laboratory | 1978-05-26 | Traditional | PDF ↗ |
| K772043 | ALPHA/CHOL | Standard Scientific, Inc. | 1977-11-28 | Traditional | PDF ↗ |
| K771833 | CHOLESTEROL | Gamma Enterprises, Inc. | 1977-10-18 | Traditional | PDF ↗ |
| K771313 | CHOLESTEROL REAGENT | Mallinckrodt Critical Care | 1977-08-03 | Traditional | PDF ↗ |
| K771093 | UNIPAK CHOLESTEROL | Harleco | 1977-07-21 | Traditional | PDF ↗ |
| K770457 | CHOLESTEROL PROCEDURE, TEKPOINT TOTAL | Icn Pharmaceuticals, Inc. | 1977-05-03 | Traditional | PDF ↗ |
Product code CGO · Class I · Clinical Chemistry. Data: openFDA.