VISUALINE METHADONE DIPSTRIPTEST


Device Classification Name

enzyme immunoassay, methadone

510(k) Number K023856
Device Name VISUALINE METHADONE DIPSTRIPTEST
Original Applicant
SUN BIOMEDICAL LABORATORIES, INC.
604 vpr center
1001 lower landing rd.
blackwood, 
NJ 
08012

Original Contact ming sun
Regulation Number 862.3620
Classification Product Code
DJR  
Date Received 11/19/2002
Decision Date 08/25/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No