510(k) K881174
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 8, 1988
- Date Received
- March 18, 1988
- 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