510(k) K974505
K974505 is an FDA 510(k) premarket notification submitted by Alfa Biotech (Uk) , Ltd. for the device "AURAFLEX FERRITIN 200 TEST PACK 80500, AURAFLEX FERRITIN CALIBRATOR PACK 80501". The FDA issued a decision of Substantially Equivalent on February 17, 1998. The device falls under product code DBF (Ferritin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5340. Alfa Biotech (Uk) , Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 17, 1998
- Date Received
- December 1, 1997
- 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