Cholestech LDX Aspartate Aminotransferase (Ast)
FDA 510(k) K032027 · Cholestech Corp.
510(k) numberK032027
Submission
- Device name
- Cholestech LDX Aspartate Aminotransferase (Ast)
- Applicant
- Cholestech Corp.
Hayward, CA, US - Received
- July 1, 2003
- Decision date
- September 5, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CIS – Hydrazone Colorimetry, Ast/Sgot
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1100
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CIS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K896238 | Cobas Ready Ast ReagentCIS · Traditional | Roche Diagnostic Systems, Inc. | 02/16/1990SE |
| K854187 | In-Vitro Test Determination of Sgot (Ast)CIS · Traditional | Clinical Data, Inc. | 11/25/1985SE |
| K812872 | Optional Total Ca-Module for Il 504/508CIS · Traditional | Instrumentation Laboratory CO | 10/26/1981SE |
| K792410 | Elvi Sgot & SGPT TransaminaseCIS · Traditional | Volu Sol Medical Industries | 12/06/1979SE |
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| K991834 | Cholestech LDX Alanine Aminotransferase (Alt), Model 11-772CKD · Traditional | 09/09/1999SE |
| K972012 | Cholestech Bun/Creatinine Test SystemCDN · Traditional | 07/24/1997SE |
| K954778 | Cholestech LDX SystemLBS · Traditional | 11/24/1995SE |
| K946067 | Total Cholesterol, HDL Cholesterol, Triglycerides and Glucose PanelCHH · Traditional | 02/22/1995SE |
| K946066 | Total Cholesterol, HDL Cholesterol and Glucose PanelCHH · Traditional | 02/22/1995SE |
| K946065 | Total Cholesterolm HDL Cholesterol and Triglycerides PanelCHH · Traditional | 02/22/1995SE |
| K946064 | Total Cholesterol CassetteCHH · Traditional | 02/22/1995SE |
| K946063 | Total Cholesterol and HDL Cholesterol PanelCHH · Traditional | 02/22/1995SE |
| K932727 | Cholestech L.D.X. SystemCGA · Traditional | 11/09/1993SE |
Questions and answers
When was Cholestech LDX Aspartate Aminotransferase (Ast) cleared by the FDA?
Cholestech LDX Aspartate Aminotransferase (Ast) (K032027) received a 510(k) decision of Substantially Equivalent on September 5, 2003, 66 days after the submission was received.
What is the product code of K032027?
The FDA product code is CIS – Hydrazone Colorimetry, Ast/Sgot, a Class II (moderate risk) device regulated under 21 CFR 862.1100.