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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fluorometer, For Clinical Use
510(k) Number K830624
Device Name FLUOROMETER, GENERAL USE
Applicant
Abbott Diagnostics
850 Maude Ave.
Mountain View,  CA  94043
Correspondent
Abbott Diagnostics
850 Maude Ave.
Mountain View,  CA  94043
Regulation Number862.2560
Classification Product Code
KHO  
Date Received02/28/1983
Decision Date 04/05/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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