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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 K013143
Device Name BENZODIAZEPINES
Applicant
Abbott Laboratories
Dept. 09va Lc-2
1920 Hurd Dr.
Irving,  TX  75038
Applicant Contact LINDA MORRIS
Correspondent
Abbott Laboratories
Dept. 09va Lc-2
1920 Hurd Dr.
Irving,  TX  75038
Correspondent Contact LINDA MORRIS
Regulation Number862.3170
Classification Product Code
JXM  
Date Received09/20/2001
Decision Date 03/13/2002
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
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