510(k) K930845
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 20, 1993
- Date Received
- February 18, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hemagglutination Inhibition, Methadone
- Device Class
- Class II
- Regulation Number
- 862.3620
- Review Panel
- TX
- Submission Type