DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS

Ldl & Vldl Precipitation, Hdl

GENERAL ATOMICS

The following data is part of a premarket notification filed by General Atomics with the FDA for Diazyme Ldl-cholesterol Reagent, Calibrator And Controls.

Pre-market Notification Details

Device IDK072523
510k NumberK072523
Device Name:DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS
ClassificationLdl & Vldl Precipitation, Hdl
Applicant GENERAL ATOMICS 12889 GREGG COURT Poway,  CA  92064
ContactCharles Yu
CorrespondentCharles Yu
GENERAL ATOMICS 12889 GREGG COURT Poway,  CA  92064
Product CodeLBR  
CFR Regulation Number862.1475 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-09-07
Decision Date2008-01-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05060500091996 K072523 000
05060500090869 K072523 000
05060500090852 K072523 000
05060500090845 K072523 000

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