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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, Benzodiazepine
510(k) Number K934869
Device Name STC DIAGNOSTICS AUTO-LYTE BENZODIAZEPINES EIA
Applicant
Solarcare Technologies Corp,Inc.
1745 Eaton Ave.
Bethlehem,  PA  18018
Applicant Contact R S NIEDBALA, PH.D
Correspondent
Solarcare Technologies Corp,Inc.
1745 Eaton Ave.
Bethlehem,  PA  18018
Correspondent Contact R S NIEDBALA, PH.D
Regulation Number862.3170
Classification Product Code
JXM  
Subsequent Product Code
DLJ  
Date Received10/12/1993
Decision Date 11/22/1993
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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