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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 the device name listed in this FDA 510(k) record. The listed applicant is Abaxis, Inc.. It received FDA 510(k) clearance on 2021-10-20 under 510(k) 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. The listed applicant is Abaxis, Inc.. The 510(k) number is K200865.

When did Piccolo Potassium Test System receive FDA 510(k) clearance?

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

Who is the listed applicant for Piccolo Potassium Test System?

The FDA 510(k) record lists Abaxis, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Official Source

View on FDA Database →

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

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