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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 K930913
Device Name COULTER MH015 (DIFFERENTIAL CELL COUNTER)
Applicant
Coulter Corp.
600 Coulter Way
Hialeah,  FL  33010
Applicant Contact BENITA BRADFORD
Correspondent
Coulter Corp.
600 Coulter Way
Hialeah,  FL  33010
Correspondent Contact BENITA BRADFORD
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received02/22/1993
Decision Date 08/23/1993
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
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