510(k) K030477 ยท NOE Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2
DIADEXUS PLAC TEST
| Applicant | Diadexus, Inc., South San Francisco CA, US |
| Decision | Substantially Equivalent, Jul 18, 2003 |
| Received | Feb 13, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030477
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.