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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name enzyme immunoassay, methadone
510(k) Number K023856
Device Name VISUALINE METHADONE DIPSTRIPTEST
Applicant
SUN BIOMEDICAL LABORATORIES, INC.
604 VPR CENTER
1001 LOWER LANDING RD.
BLACKWOOD,  NJ  08012
Applicant Contact MING SUN
Correspondent
SUN BIOMEDICAL LABORATORIES, INC.
604 VPR CENTER
1001 LOWER LANDING RD.
BLACKWOOD,  NJ  08012
Correspondent Contact MING SUN
Regulation Number862.3620
Classification Product Code
DJR  
Date Received11/19/2002
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
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