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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Centrifuge, Hematocrit
510(k) Number K925863
Device Name SPUNCRIT
Applicant
bioMerieux, Inc.
170-57 S. Commerce Way
Bethlehem,  PA  18017
Applicant Contact ROD KATZER
Correspondent
bioMerieux, Inc.
170-57 S. Commerce Way
Bethlehem,  PA  18017
Correspondent Contact ROD KATZER
Regulation Number864.6400
Classification Product Code
GKG  
Date Received11/19/1992
Decision Date 02/05/1993
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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