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 |