510(k) K863066
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 4, 1986
- Date Received
- August 12, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bathophenanthroline, Iron Binding Capacity
- Device Class
- Class I
- Regulation Number
- 862.1415
- Review Panel
- CH
- Submission Type