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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 K013882
Device Name OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I
Applicant
Orasure Technologies, Inc.
1745 Eaton Ave.
Bethlehem,  PA  18018 -1799
Applicant Contact R. SAM NIEDBALA
Correspondent
Orasure Technologies, Inc.
1745 Eaton Ave.
Bethlehem,  PA  18018 -1799
Correspondent Contact R. SAM NIEDBALA
Regulation Number862.3170
Classification Product Code
JXM  
Date Received11/23/2001
Decision Date 04/17/2002
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
Recalls CDRH Recalls
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