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 |