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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 K884346
Device Name CYTO-STAT/COULTER CLONE T11-RD1/B1-FITC MONO. ANTI
Applicant
COULTER IMMUNOLOGY
440 COULTER WAY
WEST 20TH STREET
HIALEAH,  FL  33010
Applicant Contact LEE C MATTHEWS
Correspondent
COULTER IMMUNOLOGY
440 COULTER WAY
WEST 20TH STREET
HIALEAH,  FL  33010
Correspondent Contact LEE C MATTHEWS
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received10/14/1988
Decision Date 12/27/1988
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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