The following data is part of a premarket notification filed by Diazyme Laboratories with the FDA for Diazyme 25-oh Vitamin D Assay; Diazyme 25-oh Vitamin D Control Set.
| Device ID | K133410 |
| 510k Number | K133410 |
| Device Name: | DIAZYME 25-OH VITAMIN D ASSAY; DIAZYME 25-OH VITAMIN D CONTROL SET |
| Classification | System, Test, Vitamin D |
| Applicant | DIAZYME LABORATORIES 12889 GREGG COURT Poway, CA 92064 |
| Contact | Abhijit Datta |
| Correspondent | Abhijit Datta DIAZYME LABORATORIES 12889 GREGG COURT Poway, CA 92064 |
| Product Code | MRG |
| CFR Regulation Number | 862.1825 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-07 |
| Decision Date | 2014-03-14 |
| Summary: | summary |