Medical Device Manufacturer · US , South San Francisco , CA

Diadexus, Inc.

7 submissions · 7 cleared · Since 2003

Total

Cleared

Denied

Diadexus, Inc. — FDA 510(k) Submissions

Diadexus, Inc. has submitted 7 FDA 510(k) premarket notifications since 2003, of which 7 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Test, System, Immunoassay, Lipoprotein-associated Phospholipase A2 . Use the specialty filter in the sidebar to narrow results.

7 devices

1–7 of 7

PLAC TEST FOR LP-PLA2 ACTIVITY

K141575 · NOE Test, System,... · Chemistry

Dec 2014 186d

PLAC TEST REAGENT KIT, MODELS 90107, 90112, 90115, 90116, 10-0112, 10-0113, 10-0115

K101853 · NOE Test, System,... · Chemistry

Jan 2011 186d

PLAC TEST REAGENT KIT,CALIBRATOR KIT, LP-PLA2 CONTROL KIT, MODEL(S) 90107,90109,90109

K072599 · NOE Test, System,... · Chemistry

Dec 2007 97d

MODIFICATION TO DIADEXUS PLAC TEST