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 |