The following data is part of a premarket notification filed by Diadexus, Inc. with the FDA for Plac Test Reagent Kit,calibrator Kit, Lp-pla2 Control Kit, Model(s) 90107,90109,90109.
Device ID | K072599 |
510k Number | K072599 |
Device Name: | PLAC TEST REAGENT KIT,CALIBRATOR KIT, LP-PLA2 CONTROL KIT, MODEL(S) 90107,90109,90109 |
Classification | Test, System, Immunoassay, Lipoprotein-associated Phospholipase A2 |
Applicant | DIADEXUS, INC. 343 OYSTER POINT BLVD. South San Francisco, CA 94080 |
Contact | Robert Wolfert Ph.d |
Correspondent | Robert Wolfert Ph.d DIADEXUS, INC. 343 OYSTER POINT BLVD. South San Francisco, CA 94080 |
Product Code | NOE |
Subsequent Product Code | JIT |
Subsequent Product Code | JJX |
CFR Regulation Number | 866.5600 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-09-14 |
Decision Date | 2007-12-20 |
Summary: | summary |