LFN — Nephelometric Inhibition Immunoassay, Phenobarbital Class II

FDA Device Classification

Classification Details

Product Code
LFN
Device Class
Class II
Regulation Number
862.3660
Submission Type
Review Panel
TX
Medical Specialty
Clinical Toxicology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K934388seradynQMS PHENOBARBITALFebruary 25, 1994
K864612coulter electronicsDART PHENOBARBITAL ASSAY SYSTEMJanuary 13, 1987
K860303e.i. dupont de nemours and coDUPONT PHENOBARBITAL CALIBRATORFebruary 28, 1986
K860304e.i. dupont de nemours and coDUPONT PHENOBARBITAL ASSAYFebruary 28, 1986
K821543electro-nucleonics laboratoriesIPA FOR DETECTION OF PHENOBARBITALJune 3, 1982