Piccolo Potassium Test System

Test, System, Potassium, Enzymatic Method

Abaxis, Inc.

The following data is part of a premarket notification filed by Abaxis, Inc. with the FDA for Piccolo Potassium Test System.

Pre-market Notification Details

Device IDK200865
510k NumberK200865
Device Name:Piccolo Potassium Test System
ClassificationTest, System, Potassium, Enzymatic Method
Applicant Abaxis, Inc. 3240 Whipple Road Union City,  CA  94587
ContactDennis M Bleile
CorrespondentJulie Schoell
Zoetis LLC (acquirer Of Abaxis, Inc.) 3240 Whipple Road Union City,  CA  94587
Product CodeMZV  
CFR Regulation Number862.1600 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeDual Track
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-01
Decision Date2021-10-20

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