510(k) K864168
K864168 is an FDA 510(k) premarket notification submitted by Roche Diagnostic Systems, Inc. for the device "MORPHINE ROCHE (R) EIA TEST". The FDA issued a decision of Substantially Equivalent on March 16, 1987. The device falls under product code DOE (Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.), a Class II device regulated under 21 CFR 862.3640. Roche Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 16, 1987
- Date Received
- October 24, 1986
- 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