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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Lsd (125-I)
510(k) Number K954073
Device Name STC DIAGNOSTICS LSD MICRO-PLATE EIA
Applicant
Solarcare Technologies Corp,Inc.
1745 Eaton Ave.
Bethlehem,  PA  18018
Applicant Contact R. SAM NIEDBALA
Correspondent
Solarcare Technologies Corp,Inc.
1745 Eaton Ave.
Bethlehem,  PA  18018
Correspondent Contact R. SAM NIEDBALA
Regulation Number862.3580
Classification Product Code
DLB  
Date Received08/30/1995
Decision Date 11/29/1995
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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