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 |