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Modification to Diadexus Plac Test

by Diadexus, Inc. 510(k)

Active United States

510(k) K062234

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK062234 Date11 Sep 2006ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

1 recall · FDA

    • Terminated Z-1737-2011 FDA Unclassified (pre-2012) initiated 20 Aug 2010

    Product fails stability tests prior to expiration date.

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

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