510(k) K062234 ยท NOE Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2
MODIFICATION TO DIADEXUS PLAC TEST
| Applicant | Diadexus, Inc., South San Francisco CA, US |
| Decision | Substantially Equivalent, Sep 11, 2006 |
| Received | Aug 2, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K062234
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.