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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Hematocrit, Automated
510(k) Number K864646
Device Name SORVALL CAPSPIN MICROHEMATOCRIT CENTRIFUGE
Applicant
E.I. Dupont DE Nemours & Co., Inc.
Peck'S Ln.
Newtown,  CT  06470
Applicant Contact S. H WIESENFELD
Correspondent
E.I. Dupont DE Nemours & Co., Inc.
Peck'S Ln.
Newtown,  CT  06470
Correspondent Contact S. H WIESENFELD
Regulation Number864.5600
Classification Product Code
GKF  
Date Received11/25/1986
Decision Date 01/05/1987
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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