510(k) K951319
ROCHE ABUSCREEN ONLINE FOR OPIATES 1000 TEST KIT-2000 NG/ML CUTOFF OLYMPUS AU800 INSTRUMENT APPLICATION by
Roche Diagnostic Systems, Inc.
— Product Code DOE
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 1, 1995
- Date Received
- March 23, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.
- Device Class
- Class II
- Regulation Number
- 862.3640
- Review Panel
- TX
- Submission Type