FDA Product Code
FDA Product Code NOE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5600
510(k) Clearances — 8 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K203136 | Diazyme PLAC® Test for Lp-PLA2 Activity | Diazyme Laboratories, Inc. | 2021-08-06 | Special | PDF ↗ |
| K141575 | PLAC TEST FOR LP-PLA2 ACTIVITY | Diadexus, Inc. | 2014-12-15 | Traditional | PDF ↗ |
| K101853 | PLAC TEST REAGENT KIT, MODELS 90107, 90112, 90115, 90116, 10-0112, 10-0113, 10-0115 | Diadexus, Inc. | 2011-01-03 | Traditional | PDF ↗ |
| K072599 | PLAC TEST REAGENT KIT,CALIBRATOR KIT, LP-PLA2 CONTROL KIT, MODEL(S) 90107,90109,90109 | Diadexus, Inc. | 2007-12-20 | Traditional | PDF ↗ |
| K062234 | MODIFICATION TO DIADEXUS PLAC TEST | Diadexus, Inc. | 2006-09-11 | Special | PDF ↗ |
| K050523 | DIADEXUS PLAC TEST | Diadexus, Inc. | 2005-06-15 | Traditional | PDF ↗ |
| K040101 | MODIFICATION TO DIADEXUS PLAC TEST | Diadexus, Inc. | 2004-02-05 | Special | PDF ↗ |
| K030477 | DIADEXUS PLAC TEST | Diadexus, Inc. | 2003-07-18 | Traditional | PDF ↗ |
Product code NOE · Class II · Immunology. Data: openFDA.