VISUALINE II (ALSO KNOWN AS SUNLINE) AMPHETAMINE ASSAY


Device Classification Name

enzyme immunoassay, amphetamine

510(k) Number K010177
Device Name VISUALINE II (ALSO KNOWN AS SUNLINE) AMPHETAMINE ASSAY
Original Applicant
SUN BIOMEDICAL LABORATORIES, INC.
604 vpr center
1001 lower landing rd.
blackwood, 
NJ 
08012

Original Contact ming sun
Regulation Number 862.3100
Classification Product Code
DKZ  
Date Received 01/18/2001
Decision Date 05/17/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

Type Traditional
Reviewed by Third Party No

Combination Product

No