510(k) K874484

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

K874484 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "REVISED LABELING FOR TDX PHENCYCLIDINE". The FDA issued a decision of Substantially Equivalent on November 23, 1987. 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
November 23, 1987
Date Received
October 30, 1987
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