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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polarimeter
510(k) Number K811263
Device Name TOX TM ANALYZER
Applicant
Abbott Laboratories
One Abbott Park Rd.
Abbott Park,  IL  60064
Correspondent
Abbott Laboratories
One Abbott Park Rd.
Abbott Park,  IL  60064
Regulation Number862.2050
Classification Product Code
JQZ  
Date Received05/06/1981
Decision Date 05/29/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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