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FDA 510(k)

Piccolo Potassium Test System

K-Number: K200865 · 2021-10-20

ApplicantAbaxis, Inc.
Decision Date2021-10-20
Product CodeMZV
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Piccolo Potassium Test System is a medical device manufactured by Abaxis, Inc.. It received FDA 510(k) clearance on 2021-10-20 under approval number K200865. The device is classified under product code MZV. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Piccolo Potassium Test System?

Piccolo Potassium Test System is a medical device that received FDA 510(k) clearance on 2021-10-20. It is manufactured by Abaxis, Inc.. The 510(k) number is K200865.

When was Piccolo Potassium Test System approved by the FDA?

Piccolo Potassium Test System received FDA 510(k) clearance on 2021-10-20, under approval number K200865.

What company makes Piccolo Potassium Test System?

Piccolo Potassium Test System is manufactured by Abaxis, Inc..

What is the FDA product code for Piccolo Potassium Test System?

The FDA product code for Piccolo Potassium Test System is MZV.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.