Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Diazyme PLAC® Test for Lp-PLA2 Activity

K-Number: K203136 · 2021-08-06

ApplicantDiazyme Laboratories, Inc.
Decision Date2021-08-06
Product CodeNOE
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Diazyme PLAC® Test for Lp-PLA2 Activity is a medical device manufactured by Diazyme Laboratories, Inc.. It received FDA 510(k) clearance on 2021-08-06 under approval number K203136. The device is classified under product code NOE. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Diazyme PLAC® Test for Lp-PLA2 Activity?

Diazyme PLAC® Test for Lp-PLA2 Activity is a medical device that received FDA 510(k) clearance on 2021-08-06. It is manufactured by Diazyme Laboratories, Inc.. The 510(k) number is K203136.

When was Diazyme PLAC® Test for Lp-PLA2 Activity approved by the FDA?

Diazyme PLAC® Test for Lp-PLA2 Activity received FDA 510(k) clearance on 2021-08-06, under approval number K203136.

What company makes Diazyme PLAC® Test for Lp-PLA2 Activity?

Diazyme PLAC® Test for Lp-PLA2 Activity is manufactured by Diazyme Laboratories, Inc..

What is the FDA product code for Diazyme PLAC® Test for Lp-PLA2 Activity?

The FDA product code for Diazyme PLAC® Test for Lp-PLA2 Activity is NOE.

Other Devices by Diazyme Laboratories, Inc.

K180209Diazyme 1,5-AG Assay K181438Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain Assay K180074Diazyme Lipoprotein (a) Assay K212221Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer K211648Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay K220001Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay

View all 10 devices →

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑