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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
510(k) Number K915785
Device Name STC DIAGNOSTICS BENZOYLECGONINE EIA
Applicant
Solarcare Technologies Corp,Inc.
Ben Franklin Technology Center
115 Research Dr.
Bethlehem,  PA  18015
Applicant Contact SAM NIEDBALA
Correspondent
Solarcare Technologies Corp,Inc.
Ben Franklin Technology Center
115 Research Dr.
Bethlehem,  PA  18015
Correspondent Contact SAM NIEDBALA
Regulation Number862.3250
Classification Product Code
JXO  
Date Received12/24/1991
Decision Date 03/11/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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