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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 K915441
Device Name MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGE
Applicant
Fisher Scientific Co., LLC
1410 Wayne Ave.
Indiana,  PA  15701
Applicant Contact WILLIAM CHISHKO
Correspondent
Fisher Scientific Co., LLC
1410 Wayne Ave.
Indiana,  PA  15701
Correspondent Contact WILLIAM CHISHKO
Regulation Number864.5600
Classification Product Code
GKF  
Date Received12/04/1991
Decision Date 01/08/1992
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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