510(k) K761248
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 21, 1976
- Date Received
- December 13, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Apparatus, Electrophoresis, For Clinical Use
- Device Class
- Class I
- Regulation Number
- 862.2485
- Review Panel
- CH
- Submission Type