The following data is part of a premarket notification filed by Diazyme Laboratories Inc. with the FDA for Diazyme 1,5-ag Assay.
| Device ID | K180209 |
| 510k Number | K180209 |
| Device Name: | Diazyme 1,5-AG Assay |
| Classification | Assay, 1,5-anhydroglucitol (15ag) |
| Applicant | Diazyme Laboratories Inc. 12889 Gregg Court Poway, CA 92130 |
| Contact | Abhijit Datta |
| Correspondent | Abhijit Datta Diazyme Laboratories Inc. 12889 Gregg Court Poway, CA 92130 |
| Product Code | NOZ |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-24 |
| Decision Date | 2018-10-04 |
| Summary: | summary |