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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, Cocaine And Cocaine Metabolites
510(k) Number K982759
Device Name AUTO-LYTE COCAINE METABOLITE EIA, MODEL # 1222U
Applicant
OraSure Technologies, Inc.
1745 Eaton Ave.
Bethlehem,  PA  18018
Applicant Contact R. SAM NIEDBALA
Correspondent
OraSure Technologies, Inc.
1745 Eaton Ave.
Bethlehem,  PA  18018
Correspondent Contact R. SAM NIEDBALA
Regulation Number862.3250
Classification Product Code
DIO  
Date Received08/06/1998
Decision Date 11/20/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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