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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 K870511
Device Name CHART-TYPE MICRO HEMATOCRIT TUBE READER
Applicant
Norfolk Scientific, Inc.
85 Morse St.
Norwood,  MA  02062
Applicant Contact THOMAS F KELLEY,PHD
Correspondent
Norfolk Scientific, Inc.
85 Morse St.
Norwood,  MA  02062
Correspondent Contact THOMAS F KELLEY,PHD
Regulation Number864.6400
Classification Product Code
JPI  
Date Received02/05/1987
Decision Date 03/16/1987
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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