The following data is part of a premarket notification filed by Diadexus, Inc. with the FDA for Modification To Diadexus Plac Test.
Device ID | K062234 |
510k Number | K062234 |
Device Name: | MODIFICATION TO DIADEXUS PLAC TEST |
Classification | Test, System, Immunoassay, Lipoprotein-associated Phospholipase A2 |
Applicant | DIADEXUS, INC. 343 OYSTER POINT BLVD. South San Francisco, CA 94080 |
Contact | Robert L Wolfert |
Correspondent | Robert L Wolfert DIADEXUS, INC. 343 OYSTER POINT BLVD. South San Francisco, CA 94080 |
Product Code | NOE |
CFR Regulation Number | 866.5600 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-08-02 |
Decision Date | 2006-09-11 |
Summary: | summary |