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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, Methadone
510(k) Number K000466
Device Name URINE METHADONE (METH) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 93A
Applicant
Dade Behring, Inc.
Rt. 896, Glascow Bldg. 500
Newark,  DE  19714
Applicant Contact JUDY MCINNIS-BERGER
Correspondent
Dade Behring, Inc.
Rt. 896, Glascow Bldg. 500
Newark,  DE  19714
Correspondent Contact JUDY MCINNIS-BERGER
Regulation Number862.3620
Classification Product Code
DJR  
Date Received02/11/2000
Decision Date 04/05/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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