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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 K902892
Device Name CELL-DYN CALIBRATOR
Applicant
Unipath , Ltd.
850 Maude Ave.
Mountain View,  CA  94043
Applicant Contact ANDREA HERRMANN
Correspondent
Unipath , Ltd.
850 Maude Ave.
Mountain View,  CA  94043
Correspondent Contact ANDREA HERRMANN
Regulation Number864.8165
Classification Product Code
KRZ  
Date Received07/02/1990
Decision Date 09/10/1990
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
Recalls CDRH Recalls
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