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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, Nicotine And Nicotine Metabolites
510(k) Number K974234
Device Name MICRO-PLATE COTININE EIA
Applicant
OraSure Technologies, Inc.
1745 Eaton Ave.
Bethlehem,  PA  18018
Applicant Contact SAM R NIEDBALA
Correspondent
OraSure Technologies, Inc.
1745 Eaton Ave.
Bethlehem,  PA  18018
Correspondent Contact SAM R NIEDBALA
Regulation Number862.3220
Classification Product Code
MKU  
Date Received11/12/1997
Decision Date 05/14/1998
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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