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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, Cocaine And Cocaine Metabolites
510(k) Number K934775
Device Name STC COCAINE METABOLITE EIA
Applicant
Solarcare, Inc.
115 Research Dr.
Bethlehem,  PA  18015
Applicant Contact R. SAM NIEDBALA
Correspondent
Solarcare, Inc.
115 Research Dr.
Bethlehem,  PA  18015
Correspondent Contact R. SAM NIEDBALA
Regulation Number862.3250
Classification Product Code
DIO  
Date Received10/05/1993
Decision Date 07/14/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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