510(k) K791451
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 24, 1979
- Date Received
- August 6, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antigen, Agglutinating, Echinococcus Spp.
- Device Class
- Class I
- Regulation Number
- 866.3200
- Review Panel
- MI
- Submission Type