Panels › Immunology › Product code NOE · Class 2
Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2
Regulation 866.5600
0510(k)s in 12 months (8 all time)
0recalls in 12 months (12 all time)
10recalls that name a 510(k)
Top companies in NOE
| Company | 510(k)s | Recalls |
|---|---|---|
| Diadexus, Inc. | 7 | 12 |
| Diazyme Laboratories, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 6, 2021 | K203136 | Diazyme PLAC® Test for Lp-PLA2 Activity Diazyme Laboratories, Inc. | NOE |
| 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 |
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