Piccolo Total Cholesterol Test System
FDA 510(k) K023642 · Abaxis, Inc.
510(k) numberK023642
Submission
- Device name
- Piccolo Total Cholesterol Test System
- Applicant
- Abaxis, Inc.
Union City, CA, US - Received
- October 30, 2002
- Decision date
- January 24, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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More from Axis-Shield Poc AS
| 510(k) | Device | Decision |
|---|---|---|
| K200865 | Piccolo Potassium Test SystemMZV · Dual Track | 10/20/2021SE |
| K130113 | Piccolo Lactate Test SystemKHP · Traditional | 03/11/2013SE |
| K130200 | Piccolo Total Cholesterol - Capillary Test SystemCHH · Traditional | 02/15/2013SE |
| K120664 | Piccolo Trglycerides-Capillary Test SystemJGY · Traditional | 04/24/2012SE |
| K120662 | Piccolo Hdl-Capillary Test SystemJHM · Traditional | 04/24/2012SE |
| K091052 | Piccolo C-Reactive Protein (CRP) Test SystemDCN · Traditional | 01/15/2010SE |
| K091910 | Piccolo Magnesium Test SystemJGJ · Special | 10/01/2009SE |
| K051108 | Piccolo Lactate Dephydrogenase Test SystemCFJ · Traditional | 07/08/2005SE |
| K040115 | Piccolo Magnesium Test SystemJGJ · Traditional | 01/30/2004SE |
| K023640 | Piccolo HDL Test SystemLBS · Traditional | 01/24/2003SE |
Questions and answers
When was Piccolo Total Cholesterol Test System cleared by the FDA?
Piccolo Total Cholesterol Test System (K023642) received a 510(k) decision of Substantially Equivalent on January 24, 2003, 86 days after the submission was received.
What is the product code of K023642?
The FDA product code is CHH – Enzymatic Esterase--Oxidase, Cholesterol, a Class I (low risk) device regulated under 21 CFR 862.1175.