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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 K930415
Device Name MICROHEMATOCRIT ROTOR
Applicant
Fisher Scientific Co., LLC
711 Forbes Ave.
Pittsburgh,  PA  15219
Applicant Contact DONNA CHESNA
Correspondent
Fisher Scientific Co., LLC
711 Forbes Ave.
Pittsburgh,  PA  15219
Correspondent Contact DONNA CHESNA
Regulation Number864.6400
Classification Product Code
GKG  
Date Received01/26/1993
Decision Date 03/23/1993
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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