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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 K872803
Device Name CYBERFLUOR 615 IMMUNOANALYZER
Applicant
Cyberfluor, Inc.
179 John St., 4th Floor ,
Toronto
Ontario M5t 1x4,  CA
Applicant Contact JAMES CLELLAND
Correspondent
Cyberfluor, Inc.
179 John St., 4th Floor ,
Toronto
Ontario M5t 1x4,  CA
Correspondent Contact JAMES CLELLAND
Regulation Number862.2560
Classification Product Code
KHO  
Date Received07/15/1987
Decision Date 09/02/1987
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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