510(k) K811927
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 1, 1982
- Date Received
- July 6, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioassay, Intrinsic Factor Blocking Antibody
- Device Class
- Class II
- Regulation Number
- 862.1810
- Review Panel
- CH
- Submission Type