The following data is part of a premarket notification filed by Diazyme Laboratories with the FDA for Diazyme Ferritin Assay, Diazyme Ferritin Calibrator Set, Diazyme Ferritin Control Set.
| Device ID | K133083 |
| 510k Number | K133083 |
| Device Name: | DIAZYME FERRITIN ASSAY, DIAZYME FERRITIN CALIBRATOR SET, DIAZYME FERRITIN CONTROL SET |
| Classification | Ferritin, Antigen, Antiserum, Control |
| 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 | DBF |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 866.5340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-30 |
| Decision Date | 2014-06-24 |