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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, Barbiturate
510(k) Number K934376
Device Name STC DIAGNOSTICS AUTO-LYTE BARBITURATES EIA
Applicant
Solarcare, Inc.
1745 Eaton Ave.
Bethlehem,  PA  18018 -1799
Applicant Contact R. SAM NIEDBALA
Correspondent
Solarcare, Inc.
1745 Eaton Ave.
Bethlehem,  PA  18018 -1799
Correspondent Contact R. SAM NIEDBALA
Regulation Number862.3150
Classification Product Code
DIS  
Date Received09/09/1993
Decision Date 12/07/1993
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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