The following data is part of a premarket notification filed by Diadexus, Inc. with the FDA for Plac Test For Lp-pla2 Activity.
Device ID | K141575 |
510k Number | K141575 |
Device Name: | PLAC TEST FOR LP-PLA2 ACTIVITY |
Classification | Test, System, Immunoassay, Lipoprotein-associated Phospholipase A2 |
Applicant | DIADEXUS, INC. 3 LAGOON DR. SUITE 280 Redwood Shores, CA 94065 |
Contact | Lorry Weaver Huffman |
Correspondent | Lorry Weaver Huffman DIADEXUS, INC. 3 LAGOON DR. SUITE 280 Redwood Shores, CA 94065 |
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 | 2014-06-12 |
Decision Date | 2014-12-15 |
Summary: | summary |