CARESIDE HDL-CHOLESTEROL

Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl

EXIGENT DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Exigent Diagnostics, Inc. with the FDA for Careside Hdl-cholesterol.

Pre-market Notification Details

Device IDK981899
510k NumberK981899
Device Name:CARESIDE HDL-CHOLESTEROL
ClassificationLdl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl
Applicant EXIGENT DIAGNOSTICS, INC. 6100 BRISTOL PKWY. Culver City,  CA  90230
ContactKenneth B Asarch
CorrespondentKenneth B Asarch
EXIGENT DIAGNOSTICS, INC. 6100 BRISTOL PKWY. Culver City,  CA  90230
Product CodeLBS  
CFR Regulation Number862.1475 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-06-01
Decision Date1998-07-14
Summary:summary

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