510(k) K930845
K930845 is an FDA 510(k) premarket notification submitted by Roche Diagnostic Systems, Inc. for the device "ROCHE ABUSCREEN ONTRAK FOR METHADONE". The FDA issued a decision of Substantially Equivalent on April 20, 1993. The device falls under product code DIW (Hemagglutination Inhibition, Methadone), a Class II device regulated under 21 CFR 862.3620. Roche Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.
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