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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 K993356
Device Name COULTER HEMATOLOGY ANALYZERS WITH IRF & MRV ANALYSES
Applicant
Coulter Corp.
11800 SW 147th Ave.
Mail Code 31-B06
Miami,  FL  33196 -2500
Applicant Contact STAN SUGRUE
Correspondent
Coulter Corp.
11800 SW 147th Ave.
Mail Code 31-B06
Miami,  FL  33196 -2500
Correspondent Contact STAN SUGRUE
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received10/06/1999
Decision Date 04/20/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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