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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, Amphetamine
510(k) Number K000460
Device Name URINE AMPHETAMINE/METHAMPHETAMINE (AMPH) SCREEN FLEX REAGENT, CATALOG NO. DF 90A
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 Number862.3100
Classification Product Code
DKZ  
Date Received02/11/2000
Decision Date 04/14/2000
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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