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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, Amphetamine
510(k) Number K972032
Device Name VISUALINE II METHAMPHETIMINE
Applicant
Sun Biomedical Laboratories, Inc.
2040 Fairfax Ave.
Cherry Hill,  NJ  08003
Applicant Contact MING SUN
Correspondent
Sun Biomedical Laboratories, Inc.
2040 Fairfax Ave.
Cherry Hill,  NJ  08003
Correspondent Contact MING SUN
Regulation Number862.3100
Classification Product Code
DKZ  
Date Received06/02/1997
Decision Date 08/12/1997
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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