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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 K852516
Device Name CENTIFUGE, HEMATOCRIT & MICROSEDIMENTATION COMBINE
Applicant
Whittaker General Medical
8741 Landmark Rd.
P.O. Box 27324
Richmond,  VA  23228
Applicant Contact ALFRED H GREBE
Correspondent
Whittaker General Medical
8741 Landmark Rd.
P.O. Box 27324
Richmond,  VA  23228
Correspondent Contact ALFRED H GREBE
Regulation Number864.6400
Classification Product Code
JPI  
Date Received06/13/1985
Decision Date 07/15/1985
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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