DIAZYME HDL-CHOLESTEROL REAGENT,CALIBRATOR, CONTROLS

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

DIAZYME LABORATORIES

The following data is part of a premarket notification filed by Diazyme Laboratories with the FDA for Diazyme Hdl-cholesterol Reagent,calibrator, Controls.

Pre-market Notification Details

Device IDK072395
510k NumberK072395
Device Name:DIAZYME HDL-CHOLESTEROL REAGENT,CALIBRATOR, CONTROLS
ClassificationLdl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl
Applicant DIAZYME LABORATORIES 12889 GREGG COURT Poway,  CA  92064
ContactCharles Yu
CorrespondentCharles Yu
DIAZYME LABORATORIES 12889 GREGG COURT Poway,  CA  92064
Product CodeLBS  
CFR Regulation Number862.1475 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-08-27
Decision Date2008-01-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05060500091989 K072395 000
05060500090838 K072395 000
05060500090821 K072395 000
05060500090814 K072395 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.