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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, Quinidine
510(k) Number K822653
Device Name TDX QUINIDINE
Applicant
Abbott Laboratories
One Abbott Park Rd.
Abbott Park,  IL  60064 -3500
Correspondent
Abbott Laboratories
One Abbott Park Rd.
Abbott Park,  IL  60064 -3500
Regulation Number862.3320
Classification Product Code
LBZ  
Date Received09/02/1982
Decision Date 09/28/1982
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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