510(k) K924113
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 28, 1992
- Date Received
- August 13, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hemagglutination, Cocaine Metabolites (Benzoylecgnonine)
- Device Class
- Class II
- Regulation Number
- 862.3250
- Review Panel
- TX
- Submission Type