LCL — Radioimmunoassay, Phencyclidine Class U

FDA Device Classification

Classification Details

Product Code
LCL
Device Class
Class U
Regulation Number
Submission Type
Review Panel
TX
Medical Specialty
Unknown
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K011275psychemedicsPSYCHEMEDICS RIA PHENCYCLIDINE ASSAYFebruary 11, 2002
K994093phamatechAT WORK DRUG TEST, MODEL 9145-25C; MODEL 9177-25CDecember 16, 1999
K913864immunalysis corporationPCP DIRECT RIA KIT (I-125)October 11, 1991
K890882roche diagnostic systemsABUSCREEN FP FOR PHENCYCLIDINEMarch 15, 1989
K882179syvaEMIT HVA PHENCYCLIDINE ASSAYJuly 12, 1988
K880011abbott laboratoriesREVISED LABELING FOR ADX PHENCYCLIDINEFebruary 11, 1988
K874626syvaREVISED LABELING FOR SYVA PHENCYCLIDINE ASSAYSJanuary 11, 1988
K874484abbott laboratoriesREVISED LABELING FOR TDX PHENCYCLIDINENovember 23, 1987
K830481hoffmann-la rocheABUSCREEN RADIOIMMUNOASSAY-PHENCYCLIDINEMarch 24, 1983
K800514immunalysis corporationPHENCYCLIDINE DIRECT BLOOD RIA KITMarch 19, 1980
K790655hoffmann-la rocheABUSCREEN RIA FOR PHENCYCLIDINEJune 15, 1979