Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name test, system, immunoassay, lipoprotein-associated phospholipase a2
510(k) Number K030477
Device Name DIADEXUS PLAC TEST
Applicant
DIADEXUS, INC.
343 OYSTER POINT BLVD.
SOUTH SAN FRANCISCO,  CA  94080
Applicant Contact ROBERT L WOLFERT
Correspondent
DIADEXUS, INC.
343 OYSTER POINT BLVD.
SOUTH SAN FRANCISCO,  CA  94080
Correspondent Contact ROBERT L WOLFERT
Regulation Number866.5600
Classification Product Code
NOE  
Subsequent Product Code
JJX  
Date Received02/13/2003
Decision Date 07/18/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-