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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, Theophylline
510(k) Number K860464
Device Name VISION THEOPHYLLINE - ADDIT. OF WHOLE BLOOD CLAIM
Applicant
Abbott Laboratories
One Abbott Park Rd.
Abbott Park,  IL  60064 -3500
Applicant Contact MATT KLAMRZYNSKI
Correspondent
Abbott Laboratories
One Abbott Park Rd.
Abbott Park,  IL  60064 -3500
Correspondent Contact MATT KLAMRZYNSKI
Regulation Number862.3880
Classification Product Code
KLS  
Date Received02/06/1986
Decision Date 06/17/1986
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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