Diazyme PLAC® Test for Lp-PLA2 Activity— 510(k) K203136

Name: FDA 510(k) clearance K203136
Creator: U.S. Food and Drug Administration
Published: 2021-08-06

Substantially Equivalent

Diazyme Laboratories, Inc.

FDA 510(k) clearance K203136 for Diazyme PLAC® Test for Lp-PLA2 Activity, Substantially Equivalent on 2021-08-06. Applicant: Diazyme Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Diazyme Laboratories, Inc.
Product code: Code NOE
Device class: Class 2
Regulation: 21 CFR 866.5600
Advisory panel: Immunology
Date received: 2020-10-20
Decision date: 2021-08-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Poway, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NOE

view all

K141575 — PLAC TEST FOR LP-PLA2 ACTIVITY2014-12-15
K101853 — PLAC TEST REAGENT KIT, MODELS 90107, 90112, 90115, 90116, 10-0112, 10-0113, 10-01152011-01-03
K072599 — PLAC TEST REAGENT KIT,CALIBRATOR KIT, LP-PLA2 CONTROL KIT, MODEL(S) 90107,90109,901092007-12-20
K062234 — MODIFICATION TO DIADEXUS PLAC TEST2006-09-11
K050523 — DIADEXUS PLAC TEST2005-06-15

More clearances from Diazyme Laboratories, Inc.

view all

K253069 — Lipoprotein (a) Molarity Assay2026-06-16
K252336 — Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay2026-04-24
K253358 — Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay2025-12-19
K243462 — Diazyme Colorimetric Lithium Assay2025-08-01
K211648 — Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay2022-09-08

Data sourced from openFDA. This site is unofficial and independent of the FDA.