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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 K813540
Device Name A FLUOROMETER
Applicant
American Diagnostic Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
American Diagnostic Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.2560
Classification Product Code
KHO  
Date Received12/21/1981
Decision Date 12/31/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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