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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, Cannabinoids
510(k) Number K924815
Device Name MICROPLATE CANNABINOIDS ASSAY
Applicant
Solarcare Technologies Corp,Inc.
1745 Eaton Ave.
Bethlehem,  PA  18018
Applicant Contact SAM NIEDBALA
Correspondent
Solarcare Technologies Corp,Inc.
1745 Eaton Ave.
Bethlehem,  PA  18018
Correspondent Contact SAM NIEDBALA
Regulation Number862.3870
Classification Product Code
LDJ  
Date Received09/25/1992
Decision Date 01/26/1993
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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