510(k) K955561
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 23, 1996
- Date Received
- December 6, 1995
- 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