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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator For Hemoglobin And Hematocrit Measurement
510(k) Number K854166
Device Name HEMATOLOGY CALIBRATOR CONTROL
Applicant
Interscience Diagnostics, Inc.
P.O. Box 897
Fairview,  OR  97024
Applicant Contact WILLIAM WHELPLEY
Correspondent
Interscience Diagnostics, Inc.
P.O. Box 897
Fairview,  OR  97024
Correspondent Contact WILLIAM WHELPLEY
Regulation Number864.8165
Classification Product Code
KRZ  
Date Received10/15/1985
Decision Date 03/12/1986
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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