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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Hematocrit Measuring
510(k) Number K903698
Device Name STATSPIN MICRO-HEMATOCRIT READER FOR 75MM TUBES
Applicant
STATSPIN TECHNOLOGIES
85 MORSE ST.
NORWOOD,  MA  02062
Applicant Contact THOMAS KELLEY
Correspondent
STATSPIN TECHNOLOGIES
85 MORSE ST.
NORWOOD,  MA  02062
Correspondent Contact THOMAS KELLEY
Regulation Number864.6400
Classification Product Code
JPI  
Date Received08/15/1990
Decision Date 09/17/1990
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
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