The following data is part of a premarket notification filed by Kamiya Biomedical Co. with the FDA for K-assay Ferritin (2) & Ferritin Calibrator Set.
| Device ID | K050944 |
| 510k Number | K050944 |
| Device Name: | K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SET |
| Classification | Ferritin, Antigen, Antiserum, Control |
| Applicant | KAMIYA BIOMEDICAL CO. 12779 GATEWAY DR. Seattle, WA 98168 |
| Contact | Brian Schliesman |
| Correspondent | Brian Schliesman KAMIYA BIOMEDICAL CO. 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 | 2005-04-14 |
| Decision Date | 2005-12-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816426020689 | K050944 | 000 |
| 00816426020450 | K050944 | 000 |
| 00816426020252 | K050944 | 000 |