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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, Opiates
510(k) Number K981341
Device Name STC OPIATES MICRO-PLATE EIA (ORASURE APPLICATION)
Applicant
OraSure Technologies, Inc.
1745 Eaton Ave.
Bethlehem,  PA  18018
Applicant Contact R S NIEDBALA
Correspondent
OraSure Technologies, Inc.
1745 Eaton Ave.
Bethlehem,  PA  18018
Correspondent Contact R S NIEDBALA
Regulation Number862.3650
Classification Product Code
DJG  
Date Received04/13/1998
Decision Date 05/22/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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