510(k) K772043
- Device
- ALPHA/CHOL
- Applicant
- Standard Scientific, Inc.
- 510(k) number
- K772043
- Product code
- CGO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-11-28
- Date received
- 1977-10-28
- Regulation
- 862.1175
- Classification name
- Lieberman-Burchard/Abell-Kendall, Colorimetric, Cholesterol
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3014325803
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CGO#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K850938 | CHOLESTEROL | Dilab, Inc. | 1985-06-25 |
| K811747 | KING DIAGNOSTICS CHOLESTEROL TEST | King Diagnostics, Inc. | 1981-07-10 |
| K810090 | CHOLESTEROL REAGENT | Anco Medical Reagents & Assoc. | 1981-01-26 |
| K800682 | REAGENTS FOR DETERM. CHOLESTEROL/SERUM | Diagnostic Solutions, Inc. | 1980-05-28 |
| K781611 | CHOLESTEROL DET. IN SERUM | Fisher Scientific Co., LLC | 1978-10-24 |
| K780545 | SR-PLUS DIRECT CHOLESTEROL TEST | Stanbio Laboratory | 1978-05-26 |
| K771833 | CHOLESTEROL | Gamma Enterprises, Inc. | 1977-10-18 |
| K771313 | CHOLESTEROL REAGENT | Mallinckrodt Critical Care | 1977-08-03 |
| K771093 | UNIPAK CHOLESTEROL | Harleco | 1977-07-21 |
| K770457 | CHOLESTEROL PROCEDURE, TEKPOINT TOTAL | Icn Pharmaceuticals, Inc. | 1977-05-03 |