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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, Procainamide
510(k) Number K955444
Device Name ABBOTT AXSM PROCAINAMIDE ASSAY
Applicant
Abbott Laboratories
Dept: 09v8 Bldg: Ap5-2
100 Abbott Park Rd.
Abbott Park,  IL  60064 -3500
Applicant Contact GRACE LEMIEUX
Correspondent
Abbott Laboratories
Dept: 09v8 Bldg: Ap5-2
100 Abbott Park Rd.
Abbott Park,  IL  60064 -3500
Correspondent Contact GRACE LEMIEUX
Regulation Number862.3320
Classification Product Code
LAR  
Date Received11/28/1995
Decision Date 04/02/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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