Piccolo Total Cholesterol - Capillary Test System
FDA 510(k) K130200 · Abaxis, Inc.
510(k) numberK130200
Submission
- Device name
- Piccolo Total Cholesterol - Capillary Test System
- Applicant
- Abaxis, Inc.
Union City, CA, US - Received
- January 28, 2013
- Decision date
- February 15, 2013
- 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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| K203597 | Cholesterol2CHH · Traditional | Abbott Ireland Diagnostics Division | 06/30/2022SE |
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| K163406 | Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring SystemCHH · Traditional | ACON Laboratories, Inc. | 07/11/2017SE |
| K151545 | CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System…CHH · Traditional | Polymer Technology Systems, Inc. | 12/22/2016SE |
| K150654 | CholesterolCHH · Traditional | Randox Laboratories, Ltd. | 09/29/2015SE |
| K132031 | Afinion Lipid Panel and Afinion Lipid Panel ControlCHH · Traditional | Axis-Shield Poc AS | 03/21/2014SE |
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 |
| 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 |
| K023642 | Piccolo Total Cholesterol Test SystemCHH · Traditional | 01/24/2003SE |
| K023640 | Piccolo HDL Test SystemLBS · Traditional | 01/24/2003SE |
Questions and answers
When was Piccolo Total Cholesterol - Capillary Test System cleared by the FDA?
Piccolo Total Cholesterol - Capillary Test System (K130200) received a 510(k) decision of Substantially Equivalent on February 15, 2013, 18 days after the submission was received.
What is the product code of K130200?
The FDA product code is CHH – Enzymatic Esterase--Oxidase, Cholesterol, a Class I (low risk) device regulated under 21 CFR 862.1175.