PICCOLO HDL-CAPILLARY TEST SYSTEM

Colorimetric Method, Lipoproteins

ABAXIS, INC.

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

Pre-market Notification Details

Device IDK120662
510k NumberK120662
Device Name:PICCOLO HDL-CAPILLARY TEST SYSTEM
ClassificationColorimetric Method, Lipoproteins
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 CodeJHM  
CFR Regulation Number862.1475 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-03-05
Decision Date2012-04-24
Summary:summary

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