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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 K915113
Device Name ENCORE
Applicant
Heraeus Kulzer, Inc.
430 S. Beiger St.
P.O. Box 2004
Mishawaka,  IN  46546
Applicant Contact ROSANNE M.SOVOL
Correspondent
Heraeus Kulzer, Inc.
430 S. Beiger St.
P.O. Box 2004
Mishawaka,  IN  46546
Correspondent Contact ROSANNE M.SOVOL
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received11/13/1991
Decision Date 03/18/1992
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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