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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 K955077
Device Name ANTHOS 2010 READER
Applicant
Anthos Labtec, Inc.
67 Thomas Johnson Dr.,
Suite 22
Frederick,  MD  21702
Applicant Contact NORMAN JENKINS
Correspondent
Anthos Labtec, Inc.
67 Thomas Johnson Dr.,
Suite 22
Frederick,  MD  21702
Correspondent Contact NORMAN JENKINS
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received11/06/1995
Decision Date 12/04/1995
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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