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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Whole Blood Hemoglobin Determination
510(k) Number K885227
Device Name CLINISTAT HEMOGLOBIN REAGENT TEST
Applicant
Heraeus Kulzer, Inc.
Diagnostics Division
P.O. Box 70
Elkhart,  IN  46515
Applicant Contact ROSANNE M SAVOL
Correspondent
Heraeus Kulzer, Inc.
Diagnostics Division
P.O. Box 70
Elkhart,  IN  46515
Correspondent Contact ROSANNE M SAVOL
Regulation Number864.7500
Classification Product Code
KHG  
Date Received12/20/1988
Decision Date 02/24/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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