510(k) K101853
- Device
- PLAC TEST REAGENT KIT, MODELS 90107, 90112, 90115, 90116, 10-0112, 10-0113, 10-0115
- Applicant
- DIADEXUS, INC.
- 510(k) number
- K101853
- Product code
- NOE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-01-03
- Date received
- 2010-07-01
- Regulation
- 866.5600
- Classification name
- Test, System, Immunoassay, Lipoprotein-associated Phospholipase A2
- Medical specialty
- Immunology
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- NINA PELED
- Address
- 343 Oyster Pt. Blvd. South San Francisco CA US 94080 94080
FDA Registration Numbers#
- 2032900
Source Documents#
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 |
| 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 |
| K040101 | MODIFICATION TO DIADEXUS PLAC TEST | Diadexus, Inc. | 2004-02-05 |
| K030477 | DIADEXUS PLAC TEST | Diadexus, Inc. | 2003-07-18 |
Legacy Summary#
summary
FDA Review#
Decision Summary