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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, Opiates
510(k) Number K921328
Device Name STC DIAGNOSTICS AUTO-LYTE OPIATE 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 Number862.3650
Classification Product Code
DJG  
Date Received03/18/1992
Decision Date 08/20/1992
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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