INSTANT-VIEW TCA URINE TEST


Device Classification Name

thin layer chroomatography, tricyclic antidepressant drugs

510(k) Number K022693
Device Name INSTANT-VIEW TCA URINE TEST
Original Applicant
ALFA SCIENTIFIC DESIGNS, INC.
12330 stowe dr.
poway, 
CA 
92064

Original Contact naishu wang
Regulation Number 862.3910
Classification Product Code
MLK  
Date Received 08/13/2002
Decision Date 12/09/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No