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 |