510(k) K810046
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 25, 1981
- Date Received
- January 12, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
- Device Class
- Class II
- Regulation Number
- 866.3220
- Review Panel
- MI
- Submission Type