Total Cholesterol and HDL Cholesterol Panel
FDA 510(k) K946063 · Cholestech Corp.
510(k) numberK946063
Submission
- Device name
- Total Cholesterol and HDL Cholesterol Panel
- Applicant
- Cholestech Corp.
Hayward, CA, US - Received
- November 15, 1994
- Decision date
- February 22, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CHH – Enzymatic Esterase--Oxidase, Cholesterol
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1175
- Specialty
- Clinical Chemistry
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| K040579 | Choletech LDX High-Sensitivity C-Reactive Protein (Hs-Crp)DCK · Traditional | 06/18/2004SE |
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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 |
| K932727 | Cholestech L.D.X. SystemCGA · Traditional | 11/09/1993SE |
Questions and answers
When was Total Cholesterol and HDL Cholesterol Panel cleared by the FDA?
Total Cholesterol and HDL Cholesterol Panel (K946063) received a 510(k) decision of Substantially Equivalent on February 22, 1995, 99 days after the submission was received.
What is the product code of K946063?
The FDA product code is CHH – Enzymatic Esterase--Oxidase, Cholesterol, a Class I (low risk) device regulated under 21 CFR 862.1175.