Piccolo Potassium Test System
FDA 510(k) K200865 · Abaxis, Inc.
510(k) numberK200865
Submission
- Device name
- Piccolo Potassium Test System
- Applicant
- Abaxis, Inc.
Union City, CA, US - Received
- April 1, 2020
- Decision date
- October 20, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Dual Track 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MZV – Test, System, Potassium, Enzymatic Method
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1600
- Specialty
- Clinical Chemistry
Other 510(k)s with product code MZV
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K091455 | Diazyme Liquid Stable Enzymatic Potassium Assay Kit, Model DZ113C-X, Diazyme Liquid…MZV · Traditional | Diazyme Laboratories | 08/14/2009SE |
| K053566 | Modification to: Diazyme Potassium Enzymatic Assay, Model DZ113AMZV · Special | Diazyme Laboratories | 02/15/2006SE |
| K042191 | Diazyme Potassium Enzymatic Assay KitMZV · Traditional | Diazyme Laboratories | 10/29/2004SE |
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|---|---|---|
| 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 |
| 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 Potassium Test System cleared by the FDA?
Piccolo Potassium Test System (K200865) received a 510(k) decision of Substantially Equivalent on October 20, 2021, 567 days after the submission was received.
What is the product code of K200865?
The FDA product code is MZV – Test, System, Potassium, Enzymatic Method, a Class II (moderate risk) device regulated under 21 CFR 862.1600.