510(k) K840462
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 25, 1984
- Date Received
- February 2, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioassay, Vitamin B12
- Device Class
- Class II
- Regulation Number
- 862.1810
- Review Panel
- CH
- Submission Type