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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 K935565
Device Name OPIATES MICRO-PLATE ASSAY
Applicant
Solarcare Technologies Corp,Inc.
1745 Eaton Ave.
Bethlehem,  PA  18018
Applicant Contact R. SAM NIEDBALA, PH.D.
Correspondent
Solarcare Technologies Corp,Inc.
1745 Eaton Ave.
Bethlehem,  PA  18018
Correspondent Contact R. SAM NIEDBALA, PH.D.
Regulation Number862.3650
Classification Product Code
DJG  
Date Received11/18/1993
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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