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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 K954498
Device Name FRONTLINE OPIATES
Applicant
Boehringer Mannheim Corp.
1700 Rockville Pike, Suite 450
Rockville,  MD  20852
Applicant Contact STEVE REITZLER
Correspondent
Boehringer Mannheim Corp.
1700 Rockville Pike, Suite 450
Rockville,  MD  20852
Correspondent Contact STEVE REITZLER
Regulation Number862.3650
Classification Product Code
DJG  
Date Received09/27/1995
Decision Date 03/06/1996
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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