Skip to content

Plac Test for LP-PLA2 Activity

by Diadexus, Inc. 510(k)

Active United States

510(k) K141575

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK141575 Date15 Dec 2014ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 9 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
NOE
Device Class
Class II
Regulation
21 CFR Part 866.5600
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

Other devices from Diadexus, Inc.