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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, Phencyclidine
510(k) Number K924751
Device Name SOLARCARE TECHNOLOGIES CORP. MICRO-PLATE PCP ASSAY
Applicant
Solarcare Technologies Corp,Inc.
1745 Eaton Ave.
Bethlehem,  PA  18018 -1799
Applicant Contact SAM NIEDBALA
Correspondent
Solarcare Technologies Corp,Inc.
1745 Eaton Ave.
Bethlehem,  PA  18018 -1799
Correspondent Contact SAM NIEDBALA
Classification Product Code
LCM  
Date Received09/23/1992
Decision Date 12/11/1992
Decision Substantially Equivalent (SESE)
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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