The following data is part of a premarket notification filed by Diazyme Laboratories, Inc. with the FDA for Diazyme Lipoprotein (a) Assay.
| Device ID | K180074 |
| 510k Number | K180074 |
| Device Name: | Diazyme Lipoprotein (a) Assay |
| Classification | Lipoprotein, Low-density, Antigen, Antiserum, Control |
| Applicant | Diazyme Laboratories, Inc. 12889 Gregg Court Poway, CA 92130 |
| Contact | Abhijit Datta |
| Correspondent | Abhijit Datta Diazyme Laboratories, Inc. 12889 Gregg Court Poway, CA 92064 |
| Product Code | DFC |
| CFR Regulation Number | 866.5600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-10 |
| Decision Date | 2018-03-22 |