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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 K010765
Device Name COULTER HMX ANALYZER, MODEL 6605523, COULTER HMX WITH AUTOLOADER, MODEL 6605526
Applicant
BECKMAN COULTER, INC.
11800 S.W. 14TH AVE.
P.O.BOX 169015
MIAMI,  FL  33116 -9015
Applicant Contact STAN SUGRUE
Correspondent
BECKMAN COULTER, INC.
11800 S.W. 14TH AVE.
P.O.BOX 169015
MIAMI,  FL  33116 -9015
Correspondent Contact STAN SUGRUE
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received03/14/2001
Decision Date 04/13/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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