510(k) K781403
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 21, 1978
- Date Received
- August 15, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Anti-Human Globulin, Fta-Abs Test
- Device Class
- Class II
- Regulation Number
- 866.3830
- Review Panel
- MI
- Submission Type