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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, Barbiturate
510(k) Number K014089
Device Name VISUALINE II (ALSO KNOWN AS SUNLINE) BARITURATES
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 Number862.3150
Classification Product Code
DIS  
Date Received12/11/2001
Decision Date 04/25/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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