510(k) K880011

REVISED LABELING FOR ADX PHENCYCLIDINE by Abbott Laboratories — Product Code LCL

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