The following data is part of a premarket notification filed by Diazyme Laboratories with the FDA for Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set.
| Device ID | K161721 |
| 510k Number | K161721 |
| Device Name: | Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set |
| Classification | Radioassay, Vitamin B12 |
| 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 | CDD |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-22 |
| Decision Date | 2016-09-20 |