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Plac Test Reagent Kit, Calibrator Kit, LP-PLA2 Control Kit, Model(S) 90107, 90109, 90109

by Diadexus, Inc. 510(k)

Active United States

510(k) K072599

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK072599 Date20 Dec 2007ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

7 recalls · FDA

  • 6 recalls, same reason

    • Terminated Z-1751-2010 FDA Unclassified (pre-2012) initiated 29 Oct 2009
    • Terminated Z-1752-2010 FDA Unclassified (pre-2012) initiated 29 Oct 2009
    • Terminated Z-1748-2010 FDA Unclassified (pre-2012) initiated 29 Oct 2009
    • Terminated Z-1753-2010 FDA Unclassified (pre-2012) initiated 29 Oct 2009
    • Terminated Z-1750-2010 FDA Unclassified (pre-2012) initiated 29 Oct 2009
    • Terminated Z-1749-2010 FDA Unclassified (pre-2012) initiated 29 Oct 2009

    Inaccurate results-- some samples may return with falsely elevated results potentially as a result of an interfering substance. Some patients may be subjected to additional lifestyle changes or intensified pharmaceutical therapy; such as statins, as a result of the falsely elevated result.

    • Terminated Z-1205-2009 FDA Unclassified (pre-2012) initiated 9 Feb 2009

    Premature Expiration-- the product is projected to fall short of expected shelf life, and may result in inaccurate results.

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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