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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 K780031
Device Name FLUORESCENCE DETECTOR MODEL 420
Applicant
Waters Assoc., Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Waters Assoc., Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.2560
Classification Product Code
KHO  
Date Received01/09/1978
Decision Date 01/20/1978
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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