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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 K925909
Device Name GENESIS 1, AUTOMATED CELL COUNTER, MODIFICATION
Applicant
ALICIA DIAGNOSTICS, INC.
1274 S. CENTRAL AVE.
OVIEDO,  FL  32765
Applicant Contact JOHN T TOBIN
Correspondent
ALICIA DIAGNOSTICS, INC.
1274 S. CENTRAL AVE.
OVIEDO,  FL  32765
Correspondent Contact JOHN T TOBIN
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received11/03/1992
Decision Date 10/27/1994
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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