DIADEXUS PLAC TEST— 510(k) K030477
Substantially EquivalentDiadexus, Inc.
FDA 510(k) clearance K030477 for DIADEXUS PLAC TEST, Substantially Equivalent on 2003-07-18. Applicant: Diadexus, Inc.. Device class: 2.
Clearance details
- Applicant
- Diadexus, Inc.
- Product code
- Code NOE
- Device class
- Class 2
- Regulation
- 21 CFR 866.5600
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- South San Francisco, CA, US
Recent devices under product code NOE
view all- K203136 — Diazyme PLAC® Test for Lp-PLA2 Activity
- K141575 — PLAC TEST FOR LP-PLA2 ACTIVITY
- K101853 — PLAC TEST REAGENT KIT, MODELS 90107, 90112, 90115, 90116, 10-0112, 10-0113, 10-0115
- K072599 — PLAC TEST REAGENT KIT,CALIBRATOR KIT, LP-PLA2 CONTROL KIT, MODEL(S) 90107,90109,90109
- K062234 — MODIFICATION TO DIADEXUS PLAC TEST
More clearances from Diadexus, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.