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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 K941041
Device Name SOLOR CARE TECHNOLOGIES CORPORATION OPIATES
Applicant
Solar Technologies Corp.
1745 Eaton Ave.
Bethlehem,  PA  18018
Applicant Contact SAM NIEDBALA
Correspondent
Solar Technologies Corp.
1745 Eaton Ave.
Bethlehem,  PA  18018
Correspondent Contact SAM NIEDBALA
Regulation Number862.3650
Classification Product Code
DJG  
Date Received03/07/1994
Decision Date 11/02/1994
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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