The following data is part of a premarket notification filed by Diadexus, Inc. with the FDA for Plac Test Reagent Kit,calibrator Kit, Lp-pla2 Control Kit, Model(s) 90107,90109,90109.
| Device ID | K072599 |
| 510k Number | K072599 |
| Device Name: | PLAC TEST REAGENT KIT,CALIBRATOR KIT, LP-PLA2 CONTROL KIT, MODEL(S) 90107,90109,90109 |
| Classification | Test, System, Immunoassay, Lipoprotein-associated Phospholipase A2 |
| Applicant | DIADEXUS, INC. 343 OYSTER POINT BLVD. South San Francisco, CA 94080 |
| Contact | Robert Wolfert Ph.d |
| Correspondent | Robert Wolfert Ph.d DIADEXUS, INC. 343 OYSTER POINT BLVD. South San Francisco, CA 94080 |
| 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 | 2007-09-14 |
| Decision Date | 2007-12-20 |
| Summary: | summary |