The following data is part of a premarket notification filed by Diadexus, Inc. with the FDA for Plac Test Reagent Kit, Models 90107, 90112, 90115, 90116, 10-0112, 10-0113, 10-0115.
| Device ID | K101853 |
| 510k Number | K101853 |
| Device Name: | PLAC TEST REAGENT KIT, MODELS 90107, 90112, 90115, 90116, 10-0112, 10-0113, 10-0115 |
| Classification | Test, System, Immunoassay, Lipoprotein-associated Phospholipase A2 |
| Applicant | DIADEXUS, INC. 343 OYSTER POINT BLVD. South San Francisco, CA 94080 |
| Contact | Nina Peled |
| Correspondent | Nina Peled 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 | 2010-07-01 |
| Decision Date | 2011-01-03 |
| Summary: | summary |