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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
Recalls CDRH Recalls
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