DIAZYME APOLIPOPROTEIN A-1 ASSAY

Apolipoproteins

GENERAL ATOMICS

The following data is part of a premarket notification filed by General Atomics with the FDA for Diazyme Apolipoprotein A-1 Assay.

Pre-market Notification Details

Device IDK072977
510k NumberK072977
Device Name:DIAZYME APOLIPOPROTEIN A-1 ASSAY
ClassificationApolipoproteins
Applicant GENERAL ATOMICS 12889 GREGG COURT Poway,  CA  92064
ContactAbhijit Datta
CorrespondentAbhijit Datta
GENERAL ATOMICS 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 Date2008-07-16
Summary:summary

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