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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, Methotrexate
510(k) Number K932615
Device Name TDX(R)/TDX(R)FLX(R)MEHTOTREXATE II
Applicant
Abbott Laboratories
Abbott Labs
Abbott Park,  IL  60064
Applicant Contact Irene Powers
Correspondent
Abbott Laboratories
Abbott Labs
Abbott Park,  IL  60064
Correspondent Contact Irene Powers
Classification Product Code
LAO  
Date Received06/01/1993
Decision Date 07/14/1993
Decision Substantially Equivalent (SESE)
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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