510(k) K910892
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 3, 1991
- Date Received
- March 4, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Immunoassay, Cannabinoids
- Device Class
- Class II
- Regulation Number
- 862.3870
- Review Panel
- TX
- Submission Type