Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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 the device name listed in this FDA 510(k) record. The listed applicant is Diazyme Laboratories, Inc.. It received FDA 510(k) clearance on 2021-08-06 under 510(k) 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. The listed applicant is Diazyme Laboratories, Inc.. The 510(k) number is K203136.

When did Diazyme PLAC® Test for Lp-PLA2 Activity receive FDA 510(k) clearance?

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

Who is the listed applicant for Diazyme PLAC® Test for Lp-PLA2 Activity?

The FDA 510(k) record lists Diazyme Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Diazyme Laboratories, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253069Lipoprotein (a) Molarity AssayK252336Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M AssayK253358Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain AssayK243462Diazyme Colorimetric Lithium AssayK211648Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain AssayK220001Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay

View all 19 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.

↑