The following data is part of a premarket notification filed by Diadexus, Inc. with the FDA for Diadexus Plac Test.
Device ID | K030477 |
510k Number | K030477 |
Device Name: | 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 | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-02-13 |
Decision Date | 2003-07-18 |
Summary: | summary |