PLAC TEST REAGENT KIT,CALIBRATOR KIT, LP-PLA2 CONTROL KIT, MODEL(S) 90107,90109,90109— 510(k) K072599

Name: FDA 510(k) clearance K072599
Creator: U.S. Food and Drug Administration
Published: 2007-12-20

Substantially Equivalent

Diadexus, Inc.

FDA 510(k) clearance K072599 for PLAC TEST REAGENT KIT,CALIBRATOR KIT, LP-PLA2 CONTROL KIT, MODEL(S) 90107,90109,90109, Substantially Equivalent on 2007-12-20. Applicant: Diadexus, Inc.. Device class: 2.

Clearance details

Applicant: Diadexus, Inc.
Product code: Code NOE
Device class: Class 2
Regulation: 21 CFR 866.5600
Advisory panel: Immunology
Date received: 2007-09-14
Decision date: 2007-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South San Francisco, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NOE

view all

K203136 — Diazyme PLAC® Test for Lp-PLA2 Activity2021-08-06
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
K062234 — MODIFICATION TO DIADEXUS PLAC TEST2006-09-11
K050523 — DIADEXUS PLAC TEST2005-06-15

More clearances from Diadexus, Inc.

view all

K040101 — MODIFICATION TO DIADEXUS PLAC TEST2004-02-05
K030477 — DIADEXUS PLAC TEST2003-07-18

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