PLAC TEST FOR LP-PLA2 ACTIVITY
FDA 510(k) clearance K141575 · decided 2014-12-15
Clearance details
- K-number
- K141575
- Device name
- PLAC TEST FOR LP-PLA2 ACTIVITY
- Applicant
- Diadexus, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-06-12
- Decision date
- 2014-12-15
- Days to decision
- 186 days
- Clearance type
- Traditional
- Product code
- NOE
- Device class
- 2
- Regulation number
- 866.5600
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Redwood Shores, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Diadexus
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Diazyme PLAC® Test for Lp-PLA2 Activity (K203136) | Diazyme Laboratories, Inc. | 2021-08-06 |
| PLAC TEST REAGENT KIT, MODELS 90107, 90112, 90115, 90116, 10-0112, 10-0113, 10-0115 (K101853) | Diadexus, Inc. | 2011-01-03 |
| PLAC TEST REAGENT KIT,CALIBRATOR KIT, LP-PLA2 CONTROL KIT, MODEL(S) 90107,90109,90109 (K072599) | Diadexus, Inc. | 2007-12-20 |
| MODIFICATION TO DIADEXUS PLAC TEST (K062234) | Diadexus, Inc. | 2006-09-11 |
| DIADEXUS PLAC TEST (K050523) | Diadexus, Inc. | 2005-06-15 |
| MODIFICATION TO DIADEXUS PLAC TEST (K040101) | Diadexus, Inc. | 2004-02-05 |
| DIADEXUS PLAC TEST (K030477) | Diadexus, Inc. | 2003-07-18 |
Recalls involving this device
No recalls on record reference this clearance.