Cholesterol Procedure, Tekpoint Total
FDA 510(k) K770457 · Icn Pharmaceuticals, Inc.
510(k) numberK770457
Submission
- Device name
- Cholesterol Procedure, Tekpoint Total
- Applicant
- Icn Pharmaceuticals, Inc.
Orangeburg, NY, US - Received
- March 8, 1977
- Decision date
- May 3, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CGO – Lieberman-Burchard/Abell-Kendall, Colorimetric, Cholesterol
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1175
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CGO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K850938 | CholesterolCGO · Traditional | Dilab, Inc. | 06/25/1985SE |
| K811747 | King Diagnostics Cholesterol TestCGO · Traditional | King Diagnostics, Inc. | 07/10/1981SE |
| K810090 | Cholesterol ReagentCGO · Traditional | Anco Medical Reagents & Assoc. | 01/26/1981SE |
| K800682 | Reagents for Determ. Cholesterol/SerumCGO · Traditional | Diagnostic Solutions, Inc. | 05/28/1980SE |
| K781611 | Cholesterol Det. in SerumCGO · Traditional | Fisher Scientific Co., LLC | 10/24/1978SE |
| K780545 | Sr-Plus Direct Cholesterol TestCGO · Traditional | Stanbio Laboratory | 05/26/1978SE |
| K772043 | Alpha/CholCGO · Traditional | Standard Scientific, Inc. | 11/28/1977SE |
| K771833 | CholesterolCGO · Traditional | Gamma Enterprises, Inc. | 10/18/1977SE |
| K771313 | Cholesterol ReagentCGO · Traditional | Mallinckrodt Critical Care | 08/03/1977SE |
| K771093 | Unipak CholesterolCGO · Traditional | Harleco | 07/21/1977SE |
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| K913446 | Ican Needle CountersMMK · Traditional | 09/13/1991SE |
| K904398 | Water Column Relief ValveCAF · Traditional | 07/09/1991SE |
| K770458 | Bilirubin Procedure, Tekpoint Tot & Dir.CIG · Traditional | 05/10/1977SE |
Questions and answers
When was Cholesterol Procedure, Tekpoint Total cleared by the FDA?
Cholesterol Procedure, Tekpoint Total (K770457) received a 510(k) decision of Substantially Equivalent on May 3, 1977, 56 days after the submission was received.
What is the product code of K770457?
The FDA product code is CGO – Lieberman-Burchard/Abell-Kendall, Colorimetric, Cholesterol, a Class I (low risk) device regulated under 21 CFR 862.1175.