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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name counter, cell, automated (particle counter)
510(k) Number K771107
Device Name COUNTER 700 & HC-700 HEMO 0 REF.
Original Applicant
HYCEL, INC.
Regulation Number864.5200
Classification Product Code
GKL  
Date Received06/20/1977
Decision Date 07/11/1977
Decision substantially equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
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