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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimeter, Photometer, Spectrophotometer For Clinical Use
510(k) Number K894270
Device Name DENLEY ANTHOS 2001 READER
Applicant
Denley Instruments, Inc.
4905 Pine Cone Dr., Suite 3
Durham,  NC  27707
Applicant Contact JOYCE DAVIS
Correspondent
Denley Instruments, Inc.
4905 Pine Cone Dr., Suite 3
Durham,  NC  27707
Correspondent Contact JOYCE DAVIS
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received06/22/1989
Decision Date 08/21/1989
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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