510(k) K014293
K014293 is an FDA 510(k) premarket notification submitted by Kamiya Biomedical Co. for the device "K-ASSAY FERRITIN, K-ASSAY FERRITIN CALIBRATOR SET". The FDA issued a decision of Substantially Equivalent on February 19, 2002. The device falls under product code DBF (Ferritin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5340. Kamiya Biomedical Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 19, 2002
- Date Received
- December 28, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ferritin, Antigen, Antiserum, Control
- Device Class
- Class II
- Regulation Number
- 866.5340
- Review Panel
- IM
- Submission Type