510(k) K040101
- Device
- MODIFICATION TO DIADEXUS PLAC TEST
- Applicant
- Diadexus, Inc.
- 510(k) number
- K040101
- Product code
- NOE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-02-05
- Date received
- 2004-01-20
- Regulation
- 866.5600
- Classification name
- Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Statement
- Third party reviewed
- N
Applicant Contact#
- Contact
- ROBERT L WOLFERT
- Address
- 343 Oyster Pt. Blvd. South San Francisco CA US 94080 94080
FDA Registration Numbers#
- 2032900
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code NOE#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K203136 | Diazyme PLAC® Test for Lp-PLA2 Activity | Diazyme Laboratories, Inc. | 2021-08-06 |
| K141575 | PLAC TEST FOR LP-PLA2 ACTIVITY | Diadexus, Inc. | 2014-12-15 |
| K101853 | PLAC TEST REAGENT KIT, MODELS 90107, 90112, 90115, 90116, 10-0112, 10-0113, 10-0115 | Diadexus, Inc. | 2011-01-03 |
| K072599 | PLAC TEST REAGENT KIT,CALIBRATOR KIT, LP-PLA2 CONTROL KIT, MODEL(S) 90107,90109,90109 | Diadexus, Inc. | 2007-12-20 |
| K062234 | MODIFICATION TO DIADEXUS PLAC TEST | Diadexus, Inc. | 2006-09-11 |
| K050523 | DIADEXUS PLAC TEST | Diadexus, Inc. | 2005-06-15 |
| K030477 | DIADEXUS PLAC TEST | Diadexus, Inc. | 2003-07-18 |