VISUALINE CUP IV FOR DRUGS OF ABUSE TEST FOR QUALITATIVE DETERMINATION OF COCAINE, CANNABINOIDS, MORPHINE, METHAMPHETAMI


Device Classification Name

enzyme immunoassay, cannabinoids

510(k) Number K023648
Device Name VISUALINE CUP IV FOR DRUGS OF ABUSE TEST FOR QUALITATIVE DETERMINATION OF COCAINE, CANNABINOIDS, MORPHINE, METHAMPHETAMI
Original Applicant
SUN BIOMEDICAL LABORATORIES, INC.
604 vpr center
1001 lower landing rd.
blackwood, 
NJ 
08012

Original Contact ming sun
Regulation Number 862.3870
Classification Product Code
LDJ  
Subsequent Product Codes
DIO   DJC   DJG   JXM   LCM  
Date Received 10/30/2002
Decision Date 05/06/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No