The following data is part of a premarket notification filed by Kamiya Biomedical Company with the FDA for K-assay (r) Ferritin Reagent, K-assay (r) Ferritin Calibrator.
| Device ID | K121232 |
| 510k Number | K121232 |
| Device Name: | K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATOR |
| Classification | Ferritin, Antigen, Antiserum, Control |
| Applicant | KAMIYA BIOMEDICAL COMPANY 12779 GATEWAY DR Seattle, WA 98168 |
| Contact | Shawn Kaplan |
| Correspondent | Shawn Kaplan KAMIYA BIOMEDICAL COMPANY 12779 GATEWAY DR Seattle, WA 98168 |
| Product Code | DBF |
| CFR Regulation Number | 866.5340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-24 |
| Decision Date | 2012-05-24 |
| Summary: | summary |