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510(k) K203136

Device
Diazyme PLAC® Test For Lp-PLA2 Activity
Applicant
Diazyme Laboratories Inc.
510(k) number
K203136
Product code
NOE  
Decision
Substantially Equivalent (SESE)
Decision date
2021-08-06
Date received
2020-10-20
Regulation
866.5600
Classification name
Test, System, Immunoassay, Lipoprotein-associated Phospholipase A2
Medical specialty
Immunology
Review panel
Clinical Chemistry
Device class
2
Clearance type
Special
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
Chao Dou
Address
12889 Gregg Ct. Poway CA US 92064 92064

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code NOE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K141575PLAC TEST FOR LP-PLA2 ACTIVITYDiadexus, Inc.2014-12-15
K101853PLAC TEST REAGENT KIT, MODELS 90107, 90112, 90115, 90116, 10-0112, 10-0113, 10-0115Diadexus, Inc.2011-01-03
K072599PLAC TEST REAGENT KIT,CALIBRATOR KIT, LP-PLA2 CONTROL KIT, MODEL(S) 90107,90109,90109Diadexus, Inc.2007-12-20
K062234MODIFICATION TO DIADEXUS PLAC TESTDiadexus, Inc.2006-09-11
K050523DIADEXUS PLAC TESTDiadexus, Inc.2005-06-15
K040101MODIFICATION TO DIADEXUS PLAC TESTDiadexus, Inc.2004-02-05
K030477DIADEXUS PLAC TESTDiadexus, Inc.2003-07-18

Legacy Summary#

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FDA Review#

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