The following data is part of a premarket notification filed by Diazyme Laboratories Inc. with the FDA for Diazyme Plac® Test For Lp-pla2 Activity.
| Device ID | K203136 |
| 510k Number | K203136 |
| Device Name: | Diazyme PLAC® Test For Lp-PLA2 Activity |
| Classification | Test, System, Immunoassay, Lipoprotein-associated Phospholipase A2 |
| Applicant | Diazyme Laboratories Inc. 12889 Gregg Court Poway, CA 92064 |
| Contact | Chao Dou |
| Correspondent | Chao Dou Diazyme Laboratories Inc. 12889 Gregg Court Poway, CA 92064 |
| Product Code | NOE |
| CFR Regulation Number | 866.5600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-20 |
| Decision Date | 2021-08-06 |