510(k) K890882
K890882 is an FDA 510(k) premarket notification submitted by Roche Diagnostic Systems, Inc. for the device "ABUSCREEN FP FOR PHENCYCLIDINE". The FDA issued a decision of Substantially Equivalent on March 15, 1989. The device falls under product code LCL (Radioimmunoassay, Phencyclidine), a Class U device. Roche Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 15, 1989
- Date Received
- February 21, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Phencyclidine
- Device Class
- Class U
- Regulation Number
- Review Panel
- TX
- Submission Type