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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 K853879
Device Name TDX AMPHETAMINE METHAMPHETAMINE
Applicant
Abbott Laboratories
One Abbott Park Rd.
Abbott Park,  IL  60064
Applicant Contact MARY E ZORC
Correspondent
Abbott Laboratories
One Abbott Park Rd.
Abbott Park,  IL  60064
Correspondent Contact MARY E ZORC
Regulation Number862.3100
Classification Product Code
DKZ  
Date Received09/18/1985
Decision Date 10/28/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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