DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXX

Apolipoproteins

DIAZYME LABORATORIES

The following data is part of a premarket notification filed by Diazyme Laboratories with the FDA for Diazyme Apolipoprotein B Assay, Model Dzxxx-x; B Calibrator, Model Dzxxx.

Pre-market Notification Details

Device IDK073488
510k NumberK073488
Device Name:DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXX
ClassificationApolipoproteins
Applicant DIAZYME LABORATORIES 12889 GREGG COURT Poway,  CA  92064
ContactCharles Yu
CorrespondentCharles Yu
DIAZYME LABORATORIES 12889 GREGG COURT Poway,  CA  92064
Product CodeMSJ  
Subsequent Product CodeJIT
Subsequent Product CodeJJX
CFR Regulation Number862.1475 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-10-22
Decision Date2008-03-07
Summary:summary

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