The following data is part of a premarket notification filed by Diazyme Laboratories with the FDA for Diazyme Ez Vitamin D Assay.
| Device ID | K172992 |
| 510k Number | K172992 |
| Device Name: | Diazyme EZ Vitamin D Assay |
| Classification | System, Test, Vitamin D |
| Applicant | Diazyme Laboratories 12889 Gregg Court Poway, CA 92130 |
| Contact | Abhijit Datta |
| Correspondent | Abhijit Datta Diazyme Laboratories 12889 Gregg Court Poway, CA 92130 |
| Product Code | MRG |
| CFR Regulation Number | 862.1825 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-27 |
| Decision Date | 2018-01-11 |