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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 K042724
Device Name MODIFICATION TO COULTER LH 500 HEMATOLOGY ANALYZER
Applicant
BECKMAN COULTER, INC.
11800 S.W. 147TH AVE.
MAIL CODE 31-B06
MIAMI,  FL  33196 -2500
Applicant Contact STAN SUGRUE
Correspondent
BECKMAN COULTER, INC.
11800 S.W. 147TH AVE.
MAIL CODE 31-B06
MIAMI,  FL  33196 -2500
Correspondent Contact STAN SUGRUE
Regulation Number864.5220
Classification Product Code
GKZ  
Subsequent Product Code
GKL  
Date Received10/01/2004
Decision Date 10/29/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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