510(k) K880011
K880011 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "REVISED LABELING FOR ADX PHENCYCLIDINE". The FDA issued a decision of Substantially Equivalent on February 11, 1988. The device falls under product code LCL (Radioimmunoassay, Phencyclidine), a Class U device. Abbott Laboratories has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 11, 1988
- Date Received
- January 4, 1988
- 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