PICCOLO TOTAL CHOLESTEROL TEST SYSTEM

Enzymatic Esterase--oxidase, Cholesterol

ABAXIS, INC.

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

Pre-market Notification Details

Device IDK023642
510k NumberK023642
Device Name:PICCOLO TOTAL CHOLESTEROL TEST SYSTEM
ClassificationEnzymatic Esterase--oxidase, Cholesterol
Applicant ABAXIS, INC. 3240 WHIPPLE RD. Union City,  CA  94587
ContactDennis M Bleile
CorrespondentDennis M Bleile
ABAXIS, INC. 3240 WHIPPLE RD. Union City,  CA  94587
Product CodeCHH  
CFR Regulation Number862.1175 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-10-30
Decision Date2003-01-24
Summary:summary

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