Company ยท US
DiaDexus, Inc
FDA 510(k) clearances and medical device recalls filed under this name, 2003 to 2014. Name variants (Inc, Corp, punctuation) are merged.
7510(k) clearances (0 in 12 months)
12recalls (0 in 12 months)
10recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| NOE | Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2 | 19 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 15, 2014 | K141575 | PLAC TEST FOR LP-PLA2 ACTIVITY Diadexus, Inc. | NOE |
| Jan 3, 2011 | K101853 | PLAC TEST REAGENT KIT, MODELS 90107, 90112, 90115, 90116, 10-0112, 10-0113, 10-0115 Diadexus, Inc. | NOE |
| Dec 20, 2007 | K072599 | PLAC TEST REAGENT KIT,CALIBRATOR KIT, LP-PLA2 CONTROL KIT, MODEL(S) 90107,90109,90109 Diadexus, Inc. | NOE |
| Sep 11, 2006 | K062234 | MODIFICATION TO DIADEXUS PLAC TEST Diadexus, Inc. | NOE |
| Jun 15, 2005 | K050523 | DIADEXUS PLAC TEST Diadexus, Inc. | NOE |
| Feb 5, 2004 | K040101 | MODIFICATION TO DIADEXUS PLAC TEST Diadexus, Inc. | NOE |
| Jul 18, 2003 | K030477 | DIADEXUS PLAC TEST Diadexus, Inc. | NOE |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 21, 2011 | DiaDexus, Inc diaDexus PLAC Test ELISA Kit, Enzyme Immunoassay for Quantitative Determination of Lp-PLA2 in human plasma or serum, part number 90123, manufactured by diaDexus Inc, South San Francisco. Terminated |
NOE | K062234 |
| Nov 22, 2010 | DiaDexus, Inc diaDexus PLAC Test ELISA Kit; Manufactured and distributed by diaDexus , Inc., South San Francisco, CA; Model Part Number: 90123
The diaDexusPLAC Test ELISA Kit is an enzyme Immunoassay for the quanti Terminated |
NOE | None listed |
| Jun 3, 2010 | DiaDexus, Inc PLAC Test Reagent Kit, immuno-turbidimetric method, Part Number 10-112, 10-0113, and 10-115 Advia test kit, manufactured by DiaDexus, South San Francisco, CA. Terminated |
NOE | K072599 |
| Jun 3, 2010 | DiaDexus, Inc PLAC Test Reagent Kit, immuno-turbidimetric method, Part Number 90116, 250 test kit, manufactured by DiaDexus, South San Francisco, CA. Terminated |
NOE | K072599 |
| Jun 3, 2010 | DiaDexus, Inc PLAC Test Reagent Kit, immuno-turbidimetric method, Part Number 90115, Beckman test kit, manufactured by DiaDexus, South San Francisco, CA. Terminated |
NOE | K072599 |
| Jun 3, 2010 | DiaDexus, Inc PLAC Test Reagent Kit, immuno-turbidimetric method, Part Number 90112, 50 test kit, manufactured by DiaDexus, South San Francisco, CA. Terminated |
NOE | K072599 |
| Jun 3, 2010 | DiaDexus, Inc PLAC Test Reagent Kit, immuno-turbidimetric method, Part Number 90110, 100 test kit (obsolete), manufactured by DiaDexus, South San Francisco, CA. Terminated |
NOE | K072599 |
| Jun 3, 2010 | DiaDexus, Inc PLAC Test Reagent Kit, immuno-turbidimetric method, Part Number 90107, 100 test kit, manufactured by DiaDexus, South San Francisco, CA. Terminated |
NOE | K072599 |
| Apr 23, 2009 | DiaDexus, Inc PLAC Test Calibrator Kit, Five-level liquid calibrator set for use with the diaDexus PLAC Test Reagent Kit, assembled in a kit box with an outer label, Catalog numbers 90108 and 10-0108, manufactured Terminated |
NOE | K072599 |
| Apr 1, 2009 | DiaDexus, Inc diaDexus Inc. PLAC Test Reagent Kit, Turbidimetric Immunoassay for the Quantitative Determination of Lp-PLA2 in Human Plasma or Serum, liquid ready-to-use two-reagent kit assembled in a kit box, manuf Terminated |
NOE | None listed |
| Sep 26, 2008 | DiaDexus, Inc PLAC Test ELISA kit, catalog number 90106, enzyme immunoassay for the quantitative determination of Lp-PLA2 in human plasma and serum, kit containing coated microwell stripplate and reagents (12 strip Terminated |
NOE | K030477 |
| Sep 26, 2008 | DiaDexus, Inc PLAC Test Reagent Kit, Catalog numbers 90107 and 90110, Turbidimetric Immunoassay for the Quantitative Determination of Lp-PLA2 in human plasma or serum. Product consists of a liquid, ready to use, t Terminated |
NOE | K030477 |