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 |
| 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 |
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