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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Counter, Differential Cell
510(k) Number K915071
Device Name DIFFERENTIAL COUNTING BOARD
Applicant
Biovation, Inc.
875alfred Nobel Dr.
Hercules,  CA  94547
Applicant Contact EDWIN O.BROWN
Correspondent
Biovation, Inc.
875alfred Nobel Dr.
Hercules,  CA  94547
Correspondent Contact EDWIN O.BROWN
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received11/08/1991
Decision Date 01/17/1992
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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