DIADEXUS PLAC TEST


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

Correspodent Contact robert l wolfert
Regulation Number 866.5600
Classification Product Code
NOE  
Subsequent Product Code
JJX  
Date Received 02/13/2003
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