510(k) K000662
K000662 is an FDA 510(k) premarket notification submitted by Randox Laboratories, Ltd. for the device "RANDOX FERRITIN". The FDA issued a decision of Substantially Equivalent on April 3, 2000. The device falls under product code DBF (Ferritin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5340. Randox Laboratories, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 3, 2000
- Date Received
- February 28, 2000
- 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