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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, Propoxyphene
510(k) Number K912365
Device Name TDX(R)/TDXFLX(TM) & ADX(R) PROPOXPHENE ASSAYS
Applicant
Abbott Laboratories
One Abbott Park Rd.
Abbott Park,  IL  60064 -3500
Applicant Contact CAROL M COOPER
Correspondent
Abbott Laboratories
One Abbott Park Rd.
Abbott Park,  IL  60064 -3500
Correspondent Contact CAROL M COOPER
Regulation Number862.3700
Classification Product Code
JXN  
Date Received05/29/1991
Decision Date 08/16/1991
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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