510(k) K072599 ยท NOE Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2
PLAC TEST REAGENT KIT,CALIBRATOR KIT, LP-PLA2 CONTROL KIT, MODEL(S) 90107,90109,90109
| Applicant | Diadexus, Inc., South San Francisco CA, US |
| Decision | Substantially Equivalent, Dec 20, 2007 |
| Received | Sep 14, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K072599
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.