The following data is part of a premarket notification filed by Diazyme Laboratories with the FDA for Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set.
| Device ID | K161646 |
| 510k Number | K161646 |
| Device Name: | Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set |
| Classification | Acid, Folic, Radioimmunoassay |
| 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 | CGN |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1295 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-15 |
| Decision Date | 2016-11-04 |