Diazyme PLAC® Test For Lp-PLA2 Activity

Test, System, Immunoassay, Lipoprotein-associated Phospholipase A2

Diazyme Laboratories Inc.

The following data is part of a premarket notification filed by Diazyme Laboratories Inc. with the FDA for Diazyme Plac® Test For Lp-pla2 Activity.

Pre-market Notification Details

Device IDK203136
510k NumberK203136
Device Name:Diazyme PLAC® Test For Lp-PLA2 Activity
ClassificationTest, System, Immunoassay, Lipoprotein-associated Phospholipase A2
Applicant Diazyme Laboratories Inc. 12889 Gregg Court Poway,  CA  92064
ContactChao Dou
CorrespondentChao Dou
Diazyme Laboratories Inc. 12889 Gregg Court Poway,  CA  92064
Product CodeNOE  
CFR Regulation Number866.5600 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-10-20
Decision Date2021-08-06

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