FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIADEXUS PLAC TEST
K Number: K050523
·
Decision Jun 15, 2005
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
7
Applicant Total
7
Review Days
105
Basic Information
- Device Name
- DIADEXUS PLAC TEST
- K Number
- K050523
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5600
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- DIADEXUS, INC.
- Date Received
- March 2, 2005
- Decision Date
- June 15, 2005
- Product Code
- NOE
- Advisory Committee
- Immunology
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NOE | Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2 | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NOE), ordered by most recent decision date.
Diazyme PLAC® Test for Lp-PLA2 Activity
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PLAC TEST REAGENT KIT,CALIBRATOR KIT, LP-PLA2 CONTROL KIT, MODEL(S) 90107,90109,90109
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·Immunology
MODIFICATION TO DIADEXUS PLAC TEST
FDA 510(k)
FDA Class 2
·Immunology
MODIFICATION TO DIADEXUS PLAC TEST
FDA 510(k)
FDA Class 2
·Immunology
Other Clearances by DIADEXUS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K141575 | PLAC TEST FOR LP-PLA2 ACTIVITY | Dec 15, 2014 | Substantially Equivalent |
| K101853 | PLAC TEST REAGENT KIT, MODELS 90107, 90112, 90115, 90116, 10-0112, 10-0113, 10-0115 | Jan 3, 2011 | Substantially Equivalent |
| K072599 | PLAC TEST REAGENT KIT,CALIBRATOR KIT, LP-PLA2 CONTROL KIT, MODEL(S) 90107,90109,90109 | Dec 20, 2007 | Substantially Equivalent |
| K062234 | MODIFICATION TO DIADEXUS PLAC TEST | Sep 11, 2006 | Substantially Equivalent |
| K040101 | MODIFICATION TO DIADEXUS PLAC TEST | Feb 5, 2004 | Substantially Equivalent |
| K030477 | DIADEXUS PLAC TEST | Jul 18, 2003 | Substantially Equivalent |