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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 K962988
Device Name COULTER GEN-S SYSTEM
Applicant
COULTER CORP.
11800 S.W. 147TH AVE.
MAIL CODE 31-B06
MIAMI,  FL  33196 -2500
Applicant Contact THOMAS J ENGLISH
Correspondent
COULTER CORP.
11800 S.W. 147TH AVE.
MAIL CODE 31-B06
MIAMI,  FL  33196 -2500
Correspondent Contact THOMAS J ENGLISH
Regulation Number864.5200
Classification Product Code
GKL  
Subsequent Product Code
GKJ  
Date Received08/01/1996
Decision Date 10/30/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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