510(k) K770548
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 15, 1977
- Date Received
- March 21, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plates And Equipment, Radial Immunodiffusion
- Device Class
- Class I
- Regulation Number
- 866.4800
- Review Panel
- IM
- Submission Type