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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 K915825
Device Name MARATHON 6K GENERAL-PURPOSE CENTRIFUGE
Applicant
Fisher Scientific Co., LLC
1410 Wayne Ave.
Indiana,  PA  15701
Applicant Contact WILLIAM O CLHISHKO
Correspondent
Fisher Scientific Co., LLC
1410 Wayne Ave.
Indiana,  PA  15701
Correspondent Contact WILLIAM O CLHISHKO
Regulation Number864.5600
Classification Product Code
GKF  
Date Received12/30/1991
Decision Date 03/11/1992
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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