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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 K954688
Device Name FLOW-COUNT COULTER FLUOROSPHERES
Applicant
COULTER CORP.
11800 S.W. 147TH AVE.
MIAMI,  FL  33196 -2500
Applicant Contact MARION S GAIDE
Correspondent
COULTER CORP.
11800 S.W. 147TH AVE.
MIAMI,  FL  33196 -2500
Correspondent Contact MARION S GAIDE
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received10/11/1995
Decision Date 02/29/1996
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
Recalls CDRH Recalls
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