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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 K981314
Device Name VISUALINE II (ALSO KNOWN AS SUNLINE) METHADONE
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 Received04/10/1998
Decision Date 09/04/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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